Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
2019 Possible Launch Date
S-649266 cefiderocol Shionogi/ GlaxoSmithKiline cephalosporin antibiotic Bacterial infections IV Filed NDA 8/14/2019 Yes No
A2A adenosine receptor Nouriast istradefylline Kyowa Hakko Kogyo Parkinson's disease PO Filed NDA 8/27/2019 No No antagonist
Rexista XR oxycodone ER IntelliPharmaCeutic opioid agonist Pain PO Filed NDA 8/28/2019 No No
NKTR-181 NKTR-181 Nektar opioid agonist Pain PO Filed NDA 8/29/2019 No No
phosphodiesterase-5 (PDE- tadalafil VersaFilm tadalafil VersaFilm IntelGenx Erectile dysfunction PO Filed NDA Mid-2019 Yes No 5) inhibitor fosphenytoin sodium/ fosphenytoin sodium/ sulfobutylether beta- sulfobutylether beta- Sedor anticonvulsant Seizures IM/IV Filed NDA Mid-2019 Yes No cyclodextrin sodium cyclodextrin sodium
XeriSol Glucagon glucagon Xeris glucagon analog Diabetes mellitus SC Filed NDA 9/10/2019 No No
sodium-hydrogen Irritable bowel syndrome- RDX-5791 (AZD- 1722) tenapanor Ardelyx exchanger-3 (NHE-3) PO Filed NDA 9/13/2019 No No constipation inhibitor
Imvamune; MVA- BN Imvamune; MVA-BN Bavarian Nordic vaccine Smallpox SC Filed BLA 9/15/2019 Yes No
Novo Nordisk/ Emisphere glucagon-like peptide-1 NN-9924 (OG- 217SC) semaglutide (oral) Diabetes mellitus PO Filed NDA 9/20/2019 Yes No Technologies (GLP-1) receptor agonist
Valtoco diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 2H2019 No Yes
Fasenra (self- interleukin-5 receptor (IL- benralizumab AstraZeneca Asthma SC Filed sNDA 2H2019 Yes No administered) 5R) alpha inhibitor Erythropoietic protoporphyria (EPP)/ melanocortin receptor 1 Scenesse afamelanotide Clinuvel Polymorphous light SC Filed NDA 10/6/2019 Yes Yes (MC-1) agonist eruption (PLE/PMLE)/ Vitiligo
CastiaRx.com // p: 866.516.2121 1 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
PF-708 teriparatide Pfenex/ Alvogen parathyroid hormone Osteoporosis SC Filed NDA 10/7/2019 Yes No
monomethyl fumarate Vumerity Biogen/ Alkermes Nrf2 pathway activator Multiple sclerosis (MS) PO Filed NDA 10/17/2019 Yes No (diroximel fumarate)
Noven Hisamitsu 5-HT2a and dopamine HP-3070 asenapine maleate Schizophrenia TOP Filed NDA 10/17/2019 No No Pharmaceutical D1/D2 antagonist
intraocular/ Xipere triamcinolone acetonide Clearside corticosteroid Macular edema Filed NDA 10/19/2019 Yes No subretinal
adrenocorticotropic adrenocortical synthetic ACTH depot cosyntropin Assertio INJ Filed NDA 10/19/2019 Yes No hormone (ACTH) insufficiency
FMX-101 (ARK- E021) minocycline Foamix tetracyclines Acne vulgaris TOP Filed NDA 10/20/2019 No No
alpha-1 adrenergic ET-202 phenylephrine Eton Hypotension IV Filed NDA 10/21/2019 Yes No receptor agonist
second generation JDP-205 cetirizine JDP Therapeutics Urticaria IV Filed NDA 10/30/2019 No No antihistamine
Zimhi naloxone Adamis opioid antagonist Opioid dependence IM Filed NDA 10/31/2019 No No
dihydrofolate reductase RediTrex methotrexate Cumberland Psoriasis; arthritis SC Filed NDA 11/1/2019 Yes No (DHFR) inhibitor
RNA polymerase inhibitor/ rifabutin/ amoxicillin/ Talicia RedHill Biopharma penicillin/ proton pump Bacterial infections PO Filed NDA 11/2/2019 No No pantoprazole inhibitor (PPI)
Tlando testosterone Lipocine androgen Hypogonadism PO Filed NDA 11/9/2019 No No
serotonin 5-HT1F receptor LY-573144 (COL- 144) lasmiditan Eli Lilly Acute migraines PO Filed NDA 11/14/2019 No No agonist wet age-related RTH-258 (ESBA- 1008, DLX- brolucizumab Novartis anti-VEGF antibody (neovascular) macular Intravitreal Filed BLA 11/15/2019 Yes No 1008) degeneration (AMD) ethinyl estradiol/ hormonal combination Twirla Agile Therapeutics Pregnancy prevention TOP Filed NDA 11/17/2019 No No levonorgestrel contraceptive
CastiaRx.com // p: 866.516.2121 2 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
SK YKP-3089 cenobamate undisclosed Seizure PO Filed NDA 11/21/2019 Yes No Biopharmaceuticals
Amyotrophic lateral AQST-117 riluzole Aquestive Therapeutics glutamate release inhibitor SL/ Transmucosal Filed NDA 11/30/2019 No Yes sclerosis (ALS) Modified type II activin ACE-536 (RAP- 536) luspatercept Celgene/ Acceleron receptor recombinant Anemia SC Filed BLA 12/4/2019 Yes Yes fusion protein
RVT-802 RVT-802 Enzyvant/Roivant Tissue-based therapy Congenital athymia Implant Filed NDA 12/2019 Yes Yes
calcitonin gene-related MK-1602 (AGN- 241689) ubrogepant Allergan/ Merck peptide (CGRP) receptor Acute migraines PO Filed NDA 12/15/2019 No No antagonist
IDP-123 IDP-123 Bausch Health retinoid Acne TOP Filed NDA 12/22/2019 No No
Brinavess (Kynapid) vernakalant Correvio potassium channel blocker Arrhythmia IV Filed NDA 12/24/2019 Yes No
E-2006 lemborexant Eisai/ Purdue orexin receptor antagonist Insomnia PO Filed NDA 12/27/2019 No No
ITI-007 (ITI-722) lumateperone Intra-Cellular Therapies antipsychotic Schizophrenia PO Filed NDA 12/27/2019 No No
SABER- Posidur Novartis/ Durect local anesthetic Pain SC Filed NDA 12/27/2019 No No bupivacaine CR
Human immunodeficiency S-265744 (S/GSK- 1265744) cabotegravir ViiV Healthcare HIV integrase inhibitor PO Filed NDA 12/29/2019 Yes No virus (HIV)
HIV integrase inhibitor/ cabotegravir (long-acting)/ non-nucleoside reverse TMC-278-LA ViiV Healthcare HIV-1 IM Filed NDA 12/29/2019 Yes No rilpivirine (long- acting) transcriptase inhibitor (NNRTI)
MitoGel mitomycin C UroGen alkylating agent Bladder cancer Intravesical InTrial 4Q2019 No Yes
Xyrosa doxycycline Sun Pharma tetracyclines Rosacea PO Tentative Approval 4Q2019 No No
CastiaRx.com // p: 866.516.2121 3 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
2020 Possible Launch Date
Hemolytic anti-MASP-2 monoclonal OMS-721 narsoplimab Omeros uremicsyndrome (HUS)/ IV/SC InTrial 2020 Yes Yes antibody Renal diseases
CCP-08 CCP-08 Tris Pharma undisclosed Viral rhinitis PO CRL 2020 Yes No
alpha-adrenergic Benign prostatic tamsulosin DRS tamsulosin delayed-release Veru PO InTrial 2020 No No antagonist hyperplasia (BPH)
Zalviso sufentanil, ARX- 01 AcelRx opioid analgesic Pain SL CRL 2020 Yes No
ELI-200 oxycodone/ naltrexone Elite opioid agonist Pain PO CRL 2020 No No
Sumitomo Dainippon/ non-ergoline dopamine APL-130277 apomorphine Parkinson's disease SL CRL 2020 No No MonoSol Rx/ Sunovion agonist
integrin receptor Ulcerative colitis (UC)/ Entyvio (SC formulation) vedolizumab Takeda SC Filed sBLA 1/1/2020 Yes No antagonist Crohn's disease (CD)
Aimmune/ Regeneron/ AR-101 AR-101 peanut protein capsule Peanut allergy PO Filed BLA 1/2020 No No Sanofi
SEG-101 crizanlizumab Novartis P-selectin antagonist Sickle cell disease IV Filed BLA 1/15/2020 Yes Yes
methyltransferase EZH2 E-7438 (EPZ-6438) tazemetostat Epizyme/ Eisai Sarcoma PO Filed NDA 1/23/2020 Yes Yes inhibitor
Schizophrenia/ Rykindo risperidone ER Luye atypical antipsychotic IM Filed NDA 1/28/2020 Yes No Schizoaffective disorder
gonadotropin-releasing FP-001 (LMIS) leuprolide mesylate Foresee Prostate cancer SC Filed NDA 1/29/2020 Yes No hormone (GnRH) analog
ALN-AS1 givosiran Alnylam RNAi therapeutic agent Porphyria SC Filed NDA 2/4/2020 Yes Yes
selective KIT and PDGFRa Gastrointestinal stromal BLU-285 avapritinib Blueprint Medicines PO Filed NDA 2/14/2020 Yes Yes inhibitor tumors (GIST)
CastiaRx.com // p: 866.516.2121 4 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Portage Biotech/ calcitonin gene-related BMS-927711 (BHV-3000) rimegepant sulfate Biohaven/ Bristol- Myers peptide (CGRP) receptor Acute migraines PO Filed NDA 2/20/2020 Yes No Squibb antagonist ATP citrate (pro-S)-lyase and stimulating AMP- ETC-1002 bempedoic acid Esperion Therapeutics Hypercholesterolemia PO Filed NDA 2/21/2020 No No activated protein kinase (AMPK) calcitonin gene-related ALD-403 eptinezumab Alder peptide (CGRP) receptor Migraine prevention IV/SC Filed BLA 2/22/2020 No No antagonist ATP citrate (pro-S)-lyase and stimulating AMP- ETC-1002/ bempedoic acid/ ezetimibe Esperion Therapeutics activated protein kinase Hypercholesterolemia PO Filed NDA 2/26/2020 No No ezetimibe (AMPK)/ cholesterol absorption inhibitor
CD-5789 trifarotene Galderma retinoid receptor agonist Acne TOP Filed NDA 2/28/2020 No No
Horizon/ Chugai/ Roche/ insulin-like growth factor 1 RV-001 (Roche-1, R-1507) teprotumumab Thyroid eye disease IV Filed BLA 3/6/2020 Yes Yes Genmab (IGF-1) receptor antagonist naloxone nasal spray naloxone Insys Therapeutics opioid antagonist Opioid dependence Intranasal Filed NDA 3/15/2020 No No
ASG-22M6E (ASG- 22CE, enfortumab vedotin Astellas/ Seattle Genetics nectin-4 antagonist Bladder cancer IV Filed BLA 3/16/2020 Yes No ASG-22ME)
ET-105 lamotrigine Eton anticonvulsant Epilepsy PO Filed NDA 3/17/2020 No No
cystic fibrosis transmembrane VX-445 elexacaftor Vertex Cystic fibrosis (CF) PO Filed NDA 3/20/2020 Yes No conductance regulator (CFTR) corrector sphingosine 1- phosphate 1 (S1PR1) and 5 Multiple sclerosis/ ozanimod ozanimod Celgene PO Filed NDA 3/25/2020 Yes No (S1PR5) receptor Ulcerative colitis (UC) modulator donepezil transdermal Corplex Corium International anticholinergic Alzheimer's disease TOP InTrial 1Q2020 No No system
CastiaRx.com // p: 866.516.2121 5 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
ITCA-650 exenatide sustained- glucagon-like peptide-1 (sustained release Intarcia/ Quintiles/ Servier Diabetes mellitus SC implant CRL 1Q2020 Yes No release (GLP-1) receptor agonist exenatide)
PPP-002 PPP-002 Tetra Bio-Pharma botanical drug Pain Undisclosed InTrial 1Q2020 No No
dopamine receptor Barhemsys amisulpride Acacia Nausea/ Vomiting IV CRL 1Q2020 No No antagonist
osmotic gradient Bronchitol mannitol Pharmaxis enhancer; mucus clearance Asthma/ Cystic fibrosis INH CRL 1Q2020 No Yes enhancer Graft vs. Host disease Mesoblast/ JCR/ (GvHD)/ Crohn's disease/ Prochymal remestemcel-L Mallinckrodt/ Osiris mesenchymal stem cells Gastrointestinal injury post IV InTrial 1Q2020 Yes Yes Therapeutics radiation exposure/ Heart failure (HF) aldosterone synthase LCI-699 osilodrostat Novartis Cushing's syndrome PO Filed NDA 1Q2020 No Yes inhibitor Chronic lymphocytic CD-20 monoclonal leukemia (CLL)/ Diffuse antibody/ TG-1303 ublituximab/ TGR-1202 TG Therapeutics large B-cell lymphoma IV/PO InTrial 1Q2020 Yes Yes phosphoinositide-3 kinase (DLBCL)/ Non-Hodgkin (PI3K) delta inhibitor lymphoma (NHL) sodium glucose co- transporter-2 (SGLT-2) empagliflozin, linagliptin, empagliflozin, linagliptin, Eli Lilly/ Boehringer inhibitor, dipeptidyl Diabetes mellitus PO Filed NDA 1Q2020 No No metformin XR metformin XR Ingelheim peptidase 4 (DPP4) inhibitor, biguanide Sun Pharma Advanced paclitaxel injection Breast Cancer; Lung Taclantis Research Company taxane IV Filed NDA 1Q2020 No No concentrate for suspension Cancer; Pancreatic Cancer (SPARC) bimatoprost sustained bimatoprost sustained Allergan prostaglandin agonist Glaucoma Implant Filed NDA 4/1/2020 N/A No release release Ultragenyx/ Baylor Glucose transport type 1 UX-007 triheptanoin Research Institute/ medium chain fatty acid deficiency syndrome PO Filed NDA 4/1/2020 Yes Yes Uniquest (G1DS)
CastiaRx.com // p: 866.516.2121 6 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Cosmo/ Hana/ Paion/ CNS-7056 (ONO-2745) remimazolam Pharmascience/ R- Pharm/ benzodiazepine Procedural sedation IV Filed NDA 4/3/2020 Yes No Yichang Humanwell
Viaskin Peanut Viaskin Peanut DBV Technologies Immunotherapy Peanut allergy TOP Filed BLA 4/7/2020 No No
meningococcal polysaccharide Men Quad TT (serogroups A, C, Y, and Sanofi antibacterial meninococcus/ tetanus IM Filed BLA 4/25/2020 No No W135) tetanus toxoid conjugate vaccine catechol-O- Neurocrine Biosciences/ Ongentys opicapone methyltransferase (COMT) Parkinson disease PO Filed NDA 4/26/2020 No No Bial/ Ono inhibitor Pulmonary arterial Trevyent treprostinil SteadyMed prostacyclin analog SC Filed NDA 4/27/2020 Yes Yes hypertension (PAH)
Multiple myeloma/ Acute lymphoblastic leukemia isatuximab isatuximab Sanofi/ ImmunoGen CD38 antagonist IV Filed BLA 4/30/2020 Yes Yes (ALL) or lymphoblastic lymphoma (LBL)
Attention deficit SEP-225289 (DSP- 225289, Sumitomo Dainippon/ dasotraline triple reuptake inhibitor hyperactivity disorder PO Filed NDA 5/14/2020 No No SEP-289) Sunovion (ADHD)/ Eating disorders
FMX-103 minocycline Foamix tetracyclines Rosacea TOP InTrial 6/5/2020 No No
Tentative Bafiertam monomethyl fumarate Banner Life Sciences prodrug Multiple sclerosis PO 6/20/2020 Yes No Approval
pneumococcal conjugate V-114 Merck vaccine Bacterial infection IM InTrial 2Q2020 Yes No vaccine Attention deficit D-threo- methylphenidate KP-415 KemPharm CNS stimulant hyperactivity disorder PO InTrial 2Q2020 No No controlled- release (ADHD)
Gimoti metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal CRL 2Q2020 No No
CastiaRx.com // p: 866.516.2121 7 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Pancreatic cancer/ Non- PEGPH-20 pegvorhyaluroni dase alfa Halozyme/ Nektar hyaluronic acid small cell lung cancer IV InTrial 1H2020 Yes Yes (NSCLC) VS-EBOV (rVSV- EBOV; ZEBOV Merck/ NewLink Genetics vaccine Ebola IM Filed BLA 1H2020 Yes No rVSV- ZEBOV-GP)
Lenti-D elivaldogene tavalentivec Bluebird Bio gene therapy Adrenomyeloneuropat hy Undisclosed InTrial 1H2020 Yes Yes
Breast cancer/ Pancreatic cancer/ Pancreatic cancer/ Small cell lung cancer Immunomedics/ Royalty RS7-SN-38 antibody- drug (SCLC)/ Non-small cell lung IMMU-132 sacituzumab govitecan IV CRL 1H2020 Yes Yes Pharma conjugate cancer (NSCLC)/ Colorectal cancer/ Esophageal cancer/ Urinary bladder cancer
sodium oxybate extended- FT-218 Avadel dopamine receptor agonist Narcolepsy PO InTrial 1H2020 Yes No release
Apealea (Paclical) paclitaxel Oasmia taxane Ovarian cancer IV InTrial 1H2020 Yes Yes
Acute respiratory distress Traumakine interferon-beta - 1a Faron/ Maruishi interferon IV InTrial 1H2020 Yes No syndrome (ARDS)
Polycythemia vera (PV)/ PharmaEssentia/ AOP Myelofibrosis (MF)/ ropeginterferon alfa-2b ropeginterferon alfa-2b interferon SC InTrial 1H2020 Yes Yes Orphan Essential thrombocythemia (ET)
IntelGenx / Red Hill Rizaport (VersaFilm) rizatriptan triptans Acute migraines PO CRL 1H2020 No No Biopharma
lentiviral beta- globin gene Sickle cell disease/ Beta Zynteglo (LentiGlobin) Bluebird Bio gene therapy IV InTrial 1H2020 Yes Yes transfer thalassemia
calcipotriene/ vitamin D analog/ MC2-01 (MC-201) MC2 Therapeutics Psoriasis TOP InTrial 1H2020 No No betamethasone corticosteroid selective retinoic acid Fibrodysplasia ossificans R-667 (RG-667) palovarotene Clementia/ Roche receptor agonist (RAR- PO InTrial 1H2020 Yes Yes progressiva (FOP) gamma)
CastiaRx.com // p: 866.516.2121 8 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
[fam-] trastuzumab HER2-targeting antibody- DS-8201 Daiichi Sankyo Breast cancer IV InTrial 1H2020 Yes No deruxtecan drug conjugate
interleukin-6 (IL-6) Neuromyelitis optica SA-237 (RG-6168) satralizumab Roche/ Chugai SC InTrial 1H2020 Yes Yes monoclonal antibody (NMO) hypoxia-inducible factor FibroGen/ Astellas/ FG-4592 (ASP- 1517) roxadustat prolyl hydroxylase (HIF- Anemia PO InTrial 1H2020 Yes No AstraZeneca PHI)
Cosmetic/ Cervical RT-002 daxibotulinumto xinA Revance Therapeutics botulinum toxins IM InTrial 1H2020 Yes Yes dystonia/ Plantar fasciitis
Ryplazim human plasminogen ProMetic/ Hematech plasminogen Plasminogen deficiency IV InTrial 1H2020 Yes Yes
Diffuse large B-cell lymphoma (DLBCL)/ Acute chimeric antigen receptor lymphocytic leukemia JCAR-017 lisocabtagene maraleucel Juno/ Celgene IV InTrial Mid-2020 Yes Yes (CAR) T cell therapy (ALL)/ Follicular lymphoma/ Mantle cell lymphoma
Hepatitis D (HDV); Hutchinson-Gilford Sarasar lonafarnib Eiger Biopharmaceuticals prenylation inhibitor Progeria Syndrome (HGPS PO InTrial Mid-2020 Yes Yes or progeria) and progeroid laminopathies
GlaxoSmithKline/ Seattle anti-BCMA antibody- drug GSK-2857916 GSK-2857916 Multiple myeloma SC InTrial Mid-2020 Yes Yes Genetics conjugate
mometasone furoate/ corticosteroid/ Ryaltris Glenmark Allergic rhinitis NA CRL Mid-2020 No No olopatadine HCl antihistamine long-acting beta 2 indacaterol/ adrenergic receptor glycopyrronium agonist (LABA)/ long-acting QVM-149 Novartis/ Sosei Asthma INH InTrial Mid-2020 No No bromide/mometasone muscarinic receptor furoate antagonist (LAMA)/ corticosteroid
RG-7916 (RO- 7034067) Risdiplam Roche/ PTC Therapeutics SMN2 splicing modifier Spinal muscular atrophy PO InTrial Mid-2020 Yes Yes
CastiaRx.com // p: 866.516.2121 9 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
morpholino antisense Duchenne muscular SRP-4045 casimersen Sarepta IV InTrial Mid-2020 Yes Yes oligonucleotide dystrophy (DMD)
Duchenne muscular idebenone idebenone Santhera co-enzyme Q-10 analog PO CRL Mid-2020 Yes Yes dystrophy
Pregnancy prevention/ Amphora Amphora Neothetics spermicidal agent VG CRL Mid-2020 No No Bacterial infections
GBT-440 (GTx- 011) voxelotor Global Blood Therapeutics hemoglobin modulator Sickle cell anemia PO InTrial Mid-2020 Yes Yes
Diffuse large B-cell phosphoinositide-3 kinase lymphoma (DLBCL)/ TGR-1202 umbralisib TG Therapeutics/ Rhizen PO InTrial Mid-2020 Yes Yes (PI3K) delta inhibitor Chronic lymphocytic leukemia (CLL)
3-F8 (Hu-3F8) naxitamab Y-mAbs Therapeutics GD2 antagonist Neuroblastoma IV InTrial Mid-2020 Yes Yes
cortexolone 17alpha- Winlevi/ Breezula Intrepid androgen antagonist Acne vulgaris/ alopecia TOP InTrial Mid-2020 No No propionate (CB- 03-01) daratumumab (with Johnson & Johnson humanized anti-CD38 Multiple myeloma/ Darzalex recombinant human SC Filed BLA 7/10/2020 Yes Yes / Genmab monoclonal antibody Amyloidosis hyaluronidase) valoctocogene BMN-270 BioMarin gene therapy Hemophilia IV InTrial 3Q2020 Yes Yes roxaparvovec C-C chemokine receptor 5 Tobira Therapeutics/ HIV/ Non-alcoholic TBR-652 (TAK- 652, CVC) cenicriviroc (CCR5) and receptor 2 PO InTrial 3Q2020 Yes No Takeda steatohepatitis (NASH) antagonist Hereditary angioedema BCX-7353 BCX-7353 BioCryst kallikrein inhibitor PO InTrial 3Q2020 Yes Yes (HAE)
delta-9- tetrahydrocanna PPP-001 PhytoPain Pharma cannabinoid product Pain INH InTrial 3Q2020 Yes Yes binol/ cannabidiol
Chronic kidney disease TRC-101 TRC-101 Tricida carrier protein modulator PO InTrial 3Q2020 Yes No (CKD) opioid receptor agonist Brixadi buprenorphine Camurus/ Braeburn Opioid dependence/ Pain SC Tentative Approval 11/1/2020 Yes No (partial)
CastiaRx.com // p: 866.516.2121 10 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Kidney transplant/ IdeS (immunoglobulin G- Thrombotic degrading enzyme of imlifidase Hansa Medical bacterial enzyme thrombocytopenic purpura IV InTrial 2H2020 Yes Yes Streptococcus pyogenes) (TTP)/Goodpasture's disease
selective FGFR1/2/3 INCB-54828 pemigatinib Incyte Biliary tract cancer PO InTrial 2H2020 Yes Yes inhibitor
BMS-663068 (BMS-626529 fostemsavir (temsavir Human immunodeficiency Bristol-Myers Squibb HIV attachment inhibitor PO InTrial 2H2020 Yes No prodrug) prodrug) virus (HIV)
Pulmonary arterial LIQ-861 treprostinil Liquidia Technologies prostacyclin analog INH InTrial 2H2020 Yes No hypertension (PAH)
Olinvo oliceridine Trevena opioid receptor agonist Pain IV CRL 2H2020 No No
POD- INP-104 dihydroergotami ne Impel/ 3M ergot derivative Acute migraines NA InTrial 2H2020 No No mesylate (POD-DHE)
Waldenström's selective inhibitor of Macroglobulinemia (WM)/ BGB-3111 zanubrutinib BeiGene Bruton tyrosine kinase PO InTrial 2H2020 Yes Yes Chronic lymphocytic (BTK) leukemia (CLL)
dexamethasone phosphate EGP-437 EyeGate corticosteroid Uveitis OP InTrial 2H2020 Yes No (iontophoretic)
Libervant diazepam Aquestive Therapeutics benzodiazepine Seizures SL/ Transmucosal InTrial 2H2020 No Yes
Allergic conjunctivitis/ Dry EM-100 ketotifen Eton antihistamine OP CRL 2H2020 No No eyes
HER2 oncoprotein MAGH-22 margetuximab MacroGenics/ Green Cross Breast cancer IV InTrial 2H2020 Yes No antagonist
Sci-B-Vac hepatitis B vaccine VBI Vaccines vaccine Hepatitis B (HBV) IM InTrial 2H2020 No No sulopenem sulopenem Iterum carbapenem Bacterial infection IV/PO InTrial 2H2020 No No
CastiaRx.com // p: 866.516.2121 11 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
FLT-3 receptor tyrosine Acute myeloid leukemia quizartinib quizartinib Daiichi Sankyo PO CRL 2H2020 Yes Yes kinase inhibitor (AML)
Molluscum/ Verruca VP-102 VP-102 Verrica antiviral TOP InTrial 2H2020 No No vulgaris Rheumatoid arthritis/ Crohn's disease/ Ulcerative janus associated kinase- 1 colitis (UC)/ Sjogren's GLPG-0634 filgotinib Galapagos NV/ Gilead PO InTrial 2H2020 Yes No (JAK) inhibitor syndrome/ Ankylosing spondylitis/ Psoriatic arthritis Benign prostatic NX-1207 (NYM- 4805, REC fexapotide triflutate Nymox pro-apoptotic hyperplasia (BPH)/ Intratumoral InTrial 2H2020 Yes No 0482) Prostate cancer hypoxia-inducible factor- AKB-6548 vadadustat Akebia Therapeutics prolyl hydroxylase (HIF-PH) Anemia PO InTrial 2H2020 Yes No inhibitor MediWound/ BL&H/ peptide hydrolase NexoBrid bromelain Burns/ Skin injury TOP InTrial 2H2020 No Yes CrystalGenomics/ Kaken replacement agent
Solid tumors; non- small LOXO-292 LOXO-292 Loxo Oncology/ Eli Lilly RET inhibitor cell lung cancer (NSCLC); PO InTrial 2H2020 Yes No thyroid cancer
tumor vascular disrupting Neutropenia/ Non- small NPI-2358 plinabulin BeyondSpring IV InTrial 2H2020 Yes No agent (tVDA) cell lung cancer (NSCLC)
gamma-aminobutyric acid (GABA)-ergic agonist/ baclofen/ naltrexone/ Charcot-Marie Tooth PXT-3003 Pharnext opioid receptor PO InTrial 2H2020 No Yes sorbitol disease antagonist/ sorbitol combination
ZP-4207 (ZP-GA-1) dasiglucagon Zealand Pharma glucagon analog Diabetes mellitus SC InTrial 2H2020 No Yes
Zeftera ceftobiprole Basilea cephalosporin antibiotic Bacterial infections IV InTrial 2H2020 Yes No
anti-ECAM exotoxin A Vicinium (VB-4- 845) oportuzumab monatox Eleven Biotherapeutics Bladder cancer Intravesical InTrial 2H2020 Yes No fusion protein
CastiaRx.com // p: 866.516.2121 12 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
LJPC-0118 LJPC-0118 La Jolla Pharmaceutical protozoacide Malaria Undisclosed InTrial 2H2020 No No
AstraZeneca/ Array selective MEK kinase Uveal melanoma/ Thyroid selumetinib selumetinib BioPharma/ Cancer PO InTrial 2H2020 Yes Yes inhibitor cancer Research UK
Mycapssa (Octreolin) octreotide Chiasma somatostatin analog Acromegaly PO CRL 2H2020 Yes Yes
Laboratorios Doria risperidone atypical antipsychotic Schizophrenia IM InTrial 2H2020 Yes No Farmacéuticos Rovi Acute myeloid leukemia iodine I 131 monoclonal anti-CD45 monoclonal Iomab-B Actinium (AML)/ Myelodysplastic IV InTrial 2H2020 Yes Yes antibody BC8 antibody syndrome (MDS) Attention deficity selective norepinephrine SPN-812 SPN-812 Supernus hyperactivity disorder PO InTrial 2H2020 No No reuptake inhibitor (ADHD) alpha galactosidase PRX-102 Protalix enzyme replacement Fabry disease IV InTrial 2H2020 Yes No (pegunigalsidase alfa) Otsuka/ Astex nucleoside metabolic Myelodysplastic syndrome ASTX-727 decitabine and E- 7727 PO InTrial 2H2020 Yes No Pharmaceuticals inhibitor (MDS) Niemann-Pick Disease (NPD)/ Sporadic Inclusion arimoclomol arimoclomol Orphazyme cytoprotectives Body Myositis (IBM)/ PO InTrial 2H2020 Yes Yes Amyotrophic lateral sclerosis (ALS) End stage renal diease human elastase (ESRD)/Peripheral artery PRT-201 vonapanitase Proteon Therapeutics TOP InTrial 2H2020 Yes Yes (recombinant) disease (PAD)/ Vascular access in hemodialysis chimeric antigen receptor Multiple myeloma/ Brain bb-2121 idecabtagene vicluecel Celgene/ Bluebird Bio IV InTrial 2H2020 Yes Yes (CAR) T cell therapy cancer
KPI-121 0.25% loteprednol etabonate Kala corticosteroid Dry eyes OP CRL 2H2020 No No
Age-related macular Anti-VEGF DARPin abicipar pegol Allergan VEGF-A inhibitor Intravitreal InTrial 2H2020 Yes No degeneration (AMD) dehydrated human Plantar fasciitis/ Achilles AmnioFix amnion/chorion MiMedx amniotic tissue membrane INJ InTrial 4Q2020 Yes No tendonitis/ Osteoarthritis membrane (dHACM)
CastiaRx.com // p: 866.516.2121 13 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug tramadol tramadol Avenue Therapeutics opioid receptor agonist Pain IV InTrial 4Q2020 No No
PO/SL/ Estelle estetrol/ drospirenone Mithra/ Fuji/ Zhejian Xianju estrogen receptor agonist Pregnancy prevention InTrial 4Q2020 No No Transmucosal
Infacort hydrocortisone Diurnal Group corticosteroid Adrenal insufficiency PO InTrial 4Q2020 No Yes
Diffuse large B-cell MOR-208 (MOR- 00208, lymphoma (DLBCL)/ Acute XmAB- tafasitamab MorphoSys/ Xencor CD-19 antagonist lymphocytic leukemia IV InTrial 4Q2020 Yes Yes 5574) (ALL)/ Chronic lymphocytic leukemia (CLL) Multiple myeloma/ Non- alkylating agent/ DNA Melflufen (Ygalo) melphalan- flufenamide Oncopeptides AB small cell lung cancer IV InTrial 4Q2020 No Yes synthesis inhibitor (NSCLC)/ Ovarian cancer Non-Small Cell Lung Cancer BLU-667 BLU-667 Blueprint Medicines RET inhibitor PO InTrial 4Q2020 Yes Yes (NSCLC)
Qtrypta zolmitriptan Zosano triptans Acute migraines TOP InTrial 4Q2020 No No
EUSA/ Aperion/ Endo/ Gen Qarziba (Isqette) dinutuximab beta disialoganglioside Neuroblastoma SC InTrial 2020 Yes Yes Ilac/ Medison
Leukocyte Interleukin (CS- Head and Neck cancer/ Multikine CEL-SCI immunomodulator SC InTrial 2020 Yes Yes 001P3) Squamous cell carcinoma anesthetic/ Nonsteroidal HTX-011 bupivacaine/ meloxicam Heron Therapeutics Anti- inflammatory Drug Pain Instillation CRL 2020 No No (NSAID) Chronic lymphocytic leukemia (CLL)/ Small cell ublituximab (LFB- R603, CD-20 monoclonal lymphocytic lymphoma TG20, TGTX-1101, TG- ublituximab TG Therapeutics IV InTrial 2020 Yes Yes antibody (SLL)/ Mantle cell 1101, Utuxin) lymphoma (MCL)/ Multiple sclerosis Non-small cell lung cancer INCB-028060 capmatinib Novartis/ Incyte cMET inhibitor PO InTrial 2020 Yes No (NSCLC)
Oralair Mites dust mite peptide Stallergenes/ Shionogi vaccine Dust mite allergic rhinitis SL InTrial 2020 Yes No
CastiaRx.com // p: 866.516.2121 14 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
mycolic acid biosynthesis Deltyba delamanid Otsuka Tuberculosis PO InTrial 2020 No No inhibitor
JNJ-872 (VX-787) JNJ-872 (VX-787) Johnson & Johnson/ Vertex viral protein inhibitor Influenza PO InTrial 2020 No No
sodium-dependent glucose transporter 1 (SGLT-1) and Zynquista sotagliflozin Sanofi/ Lexicon Diabetes mellitus PO CRL 2020 No No SGLT-2 inhibitor autologous chondrocyte autologous chondrocyte NeoCart Histogenics/ Purpose Joint repair Undisclosed InTrial 2020 Yes No tissue implant tissue implant
recombinant human Short stature/ Growth NNC-0195-0092 (NN-8640) somapacitan Novo Nordisk SC InTrial 2020 Yes No growth hormone (rhGH) hormone deficiency
GW Multiple sclerosis (MS)/ Sativex nabiximols cannabinoid product SL/ SPR InTrial 2020 No No Pharmaceuticals/ Otsuka Pain
Contepo fosfomycin Nabriva Therapeutics cell wall inhibitor Bacterial infections IV CRL 2020 Yes No
astodrimer sodium (SPL- VivaGel Starpharma viral attachment inhibitor Bacterial infections VG CRL 2020 No No 7013)
protein absorption CM-AT CM-AT Curemark Autism PO InTrial 2020 Yes No enhancer Acute myeloid leukemia (AML)/ Chronic Nedd 8 Activating Enzyme MLN-4924 (TAK- 92) pevonedistat Takeda myelogenous leukemia PO InTrial 2020 Yes No (NAE) antagonist (CML)/ Myelodysplastic syndrome (MDS) nonsteroidal anti- N-1539 meloxicam Recro Pharma/ Alkermes Pain IV CRL 2020 Yes No inflammatory drug (NSAID)
dopamine precursor/ dopa- ND-0612H levodopa/ carbidopa NeuroDerm Parkinson's disease (PD) SC InTrial 2020 Yes No decarboxylase inhibitor
Pedmark (STS) sodium thiosulfate Fennec reducing agent Hearing loss IV InTrial 2020 Yes Yes
Primary biliary ursodeoxycholic acid ursodeoxycholic acid Retrophin/ Asklepion bile acid derivative PO InTrial 2020 Yes No cirrhosis/cholangitits
CastiaRx.com // p: 866.516.2121 15 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug Major depressive disorder Travivo gepirone ER GSK/Fabre-Kramer 5-HT-1A receptor agonist PO CRL 2020 No No (MDD) Blepharitis/ Ocular Dexasite dexamethasone InSite Vision corticosteroid TOP InTrial 2020 No No inflammation phosphodiesterase-5 (PDE- APC-8000 tadalafil Adamis Erectile dysfunction PO CRL 2020 Yes No 5) inhibitor dopamine precursor/ dopa- ND-0612L levodopa/ carbidopa NeuroDerm Parkinson's disease (PD) SC InTrial 2020 Yes No decarboxylase inhibitor
corticosteroid/ long- acting budesonide/ muscarinic receptor Chronic obstructive BGF-MDI (PT-010) glycopyrronium/ AstraZeneca antagonist (LAMA)/ long- pulmonary diseaser INH InTrial 2020 No No formoterol acting beta 2 adrenergic (COPD)/ Asthma receptor agonist (LABA)
Tivopath (AV-951, KRN- Aveo/ Astellas/ Kyowa tivozanib VEGF inhibitor Renal cell cancer PO InTrial 2020 Yes No 951, ASP- 4130) Hakko Kirin
DS-200 DS-200 Eton undisclosed Ophthalmological disease SC InTrial 2020 unknown No
indacaterol maleate/ long-acting beta 2 agonist/ QMF-149 Novartis/ Merck Asthma INH InTrial 2020 No No mometasone furoate corticosteroid
Amyotrophic lateral BHV-0223 riluzole Biohaven glutamate release inhibitor SL/ Transmucosal CRL 2020 No Yes sclerosis (ALS)
MNK-812 oxycodone Mallinckrodt opioid agonist Pain PO CRL 2020 No No
ornithine decarboxylase Familial adenomatous Cancer Prevention inhibitor/ non-steroidal CPP-1X/ sulindac (DFMO) eflornithine/ sulindac polyposis (FAP)/ Colorectal PO InTrial 2020 Yes Yes Pharma/ Zeria anti-inflammatory drug cancer (NSAID)
neo-recombinant human GZ-402666 (NeoGAA) Sanofi enzyme therapy Pompe disease IV InTrial 2020 Yes No acid alpha glucosidase
Numbrino cocaine HCl Lannett anesthetic Anesthesia TOP CRL 2020 No No cannabidiol cannabidiol Insys Therapeutics cannabinoid product Seizures/ Prader-Willi PO InTrial Late 2020 Yes No
CastiaRx.com // p: 866.516.2121 16 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug skQ1 visomitin Mitotech plastoquinone derivative Dry eyes OP InTrial Late 2020 Yes No
neurotrophic tyrosine kinase receptor type 1 tanezumab tanezumab Pfizer/ Eli Lilly Osteoarthritis/ Pain IV/SC InTrial Late 2020 Yes No (TrkA) antagonist (monoclonal antibody) C-type natriuretic peptide BMN-111 vosoritide (vasoritide) BioMarin/ Chugai Achondroplasia SC InTrial Late 2020 Yes Yes (CNP) analog
NS-2 (ALDX-1E1, ALDX-1E2, Uveitis/ Allergic reproxalap Aldeyra Therapeutics aldehyde antagonist OP InTrial Late 2020 No No ADX- 102) conjunctivitis/ Dry eyes Acute myeloid leukemia azacitidine azacitidine Celgene DNA methylation inhibitor (AML)/ Myelodysplastic PO InTrial Late 2020 Yes Yes syndromes Non-small cell lung cancer MVA-MUC1-IL2 TG-4010 Transgene vaccine SC InTrial Late 2020 No No (NSCLC) chemoattractant receptor- QAW-039 (NVP- QAW-039) fevipiprant Novartis homologous molecule Asthma/ Atopic dermatitis PO InTrial Late 2020 Yes No (CRTH2) antagonist granulocyte macrophage- Pulmonary alveolar Molgradex molgramostim Savara INH InTrial Late 2020 Yes Yes colony stimulating factor proteinosis (PAP) Duchenne muscular gene transcription dystrophy/ Translarna ataluren PTC Therapeutics PO CRL Late 2020 Yes Yes modulator Mucopolysaccharidosis (MPS) complement C1s BIVV-009 (TNT- 009) sutimlimab Sanofi Cold agglutnin disease IV InTrial Late 2020 Yes Yes subcomponent inhibitor
sphingosine 1 phosphate RG-3477 (ACT- 128800) ponesimod Johnson & Johnson Multiple sclerosis PO InTrial Late 2020 Yes No receptor agonists
Orphan Therapeutics/ Hepato-renal syndrome Lucassin terlipressin V-1 (vasopressin) agonist IV CRL Late 2020 Yes Yes Ikaria (HRS)
HuMax-TF ADC tisotumab vedotin Genmab/ Seattle Genetics tissue factor antibody Solid tumors Undisclosed InTrial Late 2020 Yes No
phosphopantothenate RE-024 fosmetpantotena te Retrophin Neurodegeneration IV InTrial Late 2020 Yes Yes replacement therapy
CastiaRx.com // p: 866.516.2121 17 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
MK-0594 (VPD- 737) serlopitant Menlo NK-1 receptor antagonist Atopic dermatitis/ Cough PO InTrial Late 2020 Yes No
Non-cystic fibrosis Linhaliq ciprofloxacin Aradigm/ Grifols fluoroquinolone bronchiectasis/ Cystic INH CRL Late 2020 Yes Yes fibrosis Neuromyelitis optica MEDI-551 inebilizumab AstraZeneca CD-19 antagonist IV InTrial Late 2020 Yes Yes (NMO)
TSR-042 dostarlimab AnaptysBio PD-1 checkpoint inhibitor Endometrial cancer IV InTrial Late 2020 Yes No
LY-900014 (URLi) LY-900014 Eli Lilly insulins Diabetes mellitus SC InTrial Late 2020 No No
SHP-621 budesonide Shire corticosteroid Eosinophilic esophagitis PO InTrial Late 2020 Yes Yes
tetrahydrofolate iclaprim iclaprim Motif Bio Bacterial infections IV CRL Late 2020 Yes Yes dehydrogenase inhibitor
selective peroxisome Non-alcoholic GFT-505 elafibranor Genfit proliferator-activated steatohepatitis (NASH)/ PO InTrial Late 2020 No No receptor (PPAR) modulator Primary biliary cirrhosis
melanocortin 4 receptor Obesity/ Bardet-Biedl BIM-22493 (RM- 493) setmelanotide Rhythm/ Camurus/ Ipsen SC InTrial Late 2020 Yes Yes (MC4R) agonist syndrome
Scynexis/ R-Pharm JSC/ SCY-078 (MK- 3118) ibrexafungerp glucan synthase inhibitors Fungal infections IV/PO InTrial Late 2020 No Yes Merck
2021 Possible Launch Date
Furoscix furosemide scPharmaceuticals diuretic Heart failure SC CRL 1Q2021 Yes No
MK-4618 (KRP- 114V, RVT- Roivant Sciences/ Urovant/ selective beta 3 adrenergic vibegron Overactive bladder PO InTrial 1Q2021 No No 901) Kissei/ Kyorin/ Merck receptor agonist
glycolate oxidase ALNG-01 (ALN-G- 01) lumasiran Alnylam Hyperoxaluria Intranasal InTrial 1Q2021 Yes Yes antagonist
CastiaRx.com // p: 866.516.2121 18 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug Sun Pharma Advanced SDP-037, SDN-037 SDP-037, SDN- 037 Research Company Corticosteroid Ocular inflammation/pain OP InTrial 2Q2021 No No (SPARC) Psoriasis(Ps)/ Psoriatic interleukin-17 (IL-17) arthritis (PsA)/ Ankylosing UCB-4940 (CDP- 4940) bimekizumab UCB IV InTrial 1H2021 Yes No receptor inhibitor spondylitis (AS)/ Rheumatoid arthritis (RA) RGN-259 (GBT- 201; RGN- Neurotrophic keratitis thymosin beta 4 RegeneRx actin regulating peptide OP InTrial 1H2021 No Yes 352) (NK)/ Dry eyes
Duchenne muscular WVE-210201 WVE-210201 Wave Life Sciences oligonucleotide IV InTrial 1H2021 Yes Yes dystrophy (DMD)
ACER-001 sodium phenylbutyrate Acer Therapeutics BCKDC kinase inhibitor Maple Syrup Urine Disease PO InTrial 1H2021 No Yes
N-methyl-D-aspartate Treatment-resistant dextromethorph an/ AXS-05 Axsome (NMDA) antagonist/ depression/ Alzheimer's PO InTrial 1H2021 No No bupropion antidepressant disease TransCon Growth Short stature/ Growth ACP-001 Ascendis growth hormone prodrug SC InTrial 1H2021 Yes No Hormone hormone deficiency
C5a receptor (C5aR) CCX-168 avacopan ChemoCentryx/ Galencia Vasculitis/ Glomerulopathy PO InTrial 1H2021 Yes Yes antagonist GSK/ Celestial/ Roivant therapeutic aryl Atopic dermatitis (AD)/ GSK-2894512 (WBI-1001) tapinarof Sciences/ Welichem hydrocarbon receptor TOP InTrial 1H2021 Yes No Psoriasis Biotech modulating agent (TAMA) phosphodiesterase type 5 Benign prostatic TadFin tadalafil and finasteride Veru inhibitor /5-alpha- PO InTrial Mid-2021 No No hyperplasia (BPH) reductase inhibitor Atara Biotherapeutics/ Lymphoproliferative EBV-CTL (ATA- 129) tabelecleucel Memorial Sloan- Kettering cell therapy IV InTrial Mid-2021 Yes Yes disorder Cancer Center respiratory syncytial virus Respiratory syncytial virus RSV-F (ResVax) Novavax vaccine IM InTrial Mid-2021 Yes No vaccine (RSV) infection
Recorlev levoketoconazol e Strongbridge Biopharma azole antifungal Cushing's syndrome PO InTrial 3Q2021 No Yes
Sun Pharma Advanced PDP-716 brimonidine Research Company alpha-2 agonist Glaucoma OP InTrial 3Q2021 No No (SPARC)
CastiaRx.com // p: 866.516.2121 19 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
dexamethasone sustained- Otividex Otonomy corticosteroid Meniere's disease Intratympanic InTrial 2H2021 Yes No release
Duchenne muscular VBP-15 vamorolone Santhera corticosteroid PO InTrial 2H2021 Yes Yes dystrophy (DMD)
Calliditas/ Kyowa Hakko PL-56 budesonide corticosteroid Nephropathy PO InTrial 2H2021 No No Kirin
TWIN (S6G5T-1; S6G5T-3) benzoyl peroxide/ tretinoin Sol-Gel Technologies retinoid Acne vulgaris TOP InTrial 2H2021 No No
177Lu-PSMA-617 Lutetium Endocyte Radiopharmaceutical Prostate cancer IV InTrial 2H2021 Yes No
tumor infiltrating LN-145 lifileucel Iovance Biotherapeutics Cervical Cancer IV InTrial 2H2021 Yes No lymphocyte
GS-010 GS-010 GenSight Biologics gene therapy Optic neuropathy Intraocular InTrial 2H2021 Yes Yes
digitalis-like factor AMAG-423 digoxin immune fab (DIF) AMAG/ Velo Preeclampsia IV InTrial 2H2021 Yes Yes antagonist Attention deficit SPN-810 molindone Supernus atypical antipsychotic hyperactivity disorder PO InTrial 2H2021 No No (ADHD) R-1658 (RG-1658, JTT-705, DalCor/ Japan Tobacco/ cholesteryl ester transfer Acute coronary syndrome dalcetrapib PO InTrial 2021 Yes No RO- 4607381) Roche protein inhibitor (ACS)
Cara Therapeutics/ Vifor/ Pruritus/ Pain/ Korsuva difelikefalin opioid receptor agonist IV/PO InTrial 2021 No No Fresenius Osteoarthritis Adenosine deaminase ADA-transduced (ADA)-deficient severe OTL-101 autologous stem cell Orchard Therapeutics gene therapy Undisclosed InTrial 2021 Yes Yes combined therapy immunodeficiency (SCID) Roche/ Bristol- Myers Duchenne muscular BMS-986089 (RG- 6206) BMS-986089 (RG-6206) anti-myostatin adnectin SC InTrial 2021 Yes Yes Squibb dystrophy (DMD) Renal cell cancer (RCC)/ AstraZeneca (Hutchison c-Met receptor tyrosine AZD-6094 (HMPL- 504) savolitinib (volitinib) Non-small cell lung cancer PO InTrial 2021 Yes No MediPharma) kinase inhibitor (NSCLC)
CastiaRx.com // p: 866.516.2121 20 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
adrenocorticotropic CT-100 corticotrophin Eton Rheumatoid arthritis (RA) INJ InTrial 2021 No No hormone (ACTH)
Irritable bowel disease SHP-647 (PF- 00547659) SHP-647 (PF- 00547659) Shire MAdCAM-1 antagonist (IBD)/ Crohn's disease IV/SC InTrial 2021 Yes Yes (CD)/ Ulcerative colitis (UC)
Chronic myelogenous ABL-001 asciminib Novartis allosteric Bcr-Abl inhibitor PO InTrial 2021 Yes Yes leukemia (CML) Adenovirus/ brincidofovir DNA-directed DNA CMX-001 Chimerix Cytomegalovirus (CMV)/ PO InTrial 2021 No Yes hexadecyloxypro pyl ester polymerase inhibitor Smallpox
S5G4T-1 (DER-45- EV) benzoyl peroxide Sol-Gel Technologies benzoyl peroxide Rosacea TOP InTrial 2021 No No
chemokine (CXCR4) POL-6326 balixafortide Polyphor Transplant/ Breast cancer IV InTrial 2021 Yes No antagonist
DS-100 DS-100 Eton undisclosed Ophthalmological disease SC InTrial 2021 unknown No
Qizenday MD-1003 MedDay biotin Multiple sclerosis PO InTrial 2021 Yes No
ARYx Therapeutics/ vitamin K epoxide ATI-5923 tecarfarin Anticoagulation PO InTrial 2021 No No Armetheon reductase enzyme inhibitor
V1A vasopressin receptor RG-7314 (RO- 5285119) balovaptan Roche Autism spectrum disorder PO InTrial 2021 Yes No antagonist
alpha-2/beta-1 adrenergic vascular Ehlers-Danlos Edsivo celiprolol HCl Acer Therapeutics PO CRL 2021 Yes Yes agent Syndrome (vEDS)
OSE-2101 (IDM- 2101, EP- Non-small cell lung cancer tedopi OSE Pharma/ Takeda vaccine SC InTrial 2021 Yes Yes 2101) (NSCLC)
neurokinin 1 receptor (NK- LY-686017 tradipitant Vanda Pharmaceuticals Motion sickness PO InTrial 2021 No No 1R) antagonist
toll-like receptor 9 (TLR- IMO-2125 tilsotolimod Idera Melanoma SC/ intratumoral InTrial 2021 Yes Yes 9) agonist
beta-amyloid (Abeta) gantenerumab gantenerumab Roche Alzheimer's disease SC InTrial Late 2021 Yes No inhibitor
CastiaRx.com // p: 866.516.2121 21 Brand Pipeline Forecast 3rd Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug paroxysmal nocturnal hemoglobinuria (PNH); Ultomiris SC ravulizumab- cwvz Alexion C5 complement inhibitor SC InTrial Late 2021 Yes Yes Hemolytic uremic syndrome (HUS) wet age-related macular ONS-5010 bevacizumab Outlook Therapeutics anti-VEGF antibody Intravitreal InTrial Late 2021 Yes No degeneration
multivalent group B PF-06482077 Pfizer vaccine Bacterial infection IM InTrial Late 2021 Yes No streptococcus vaccine
Duchenne muscular CAT-1004 edasalonexent Catabasis NF-kB inhibitor PO InTrial Late 2021 Yes Yes dystrophy (DMD) End-stage renal disease Humacyl human acellular vessel Humacyte cellular therapy (ESRD)/ Peripheral artery Implant InTrial Late 2021 Yes No disease (PAD)
AMT-061 AMT-061 uniQure gene therapy Hemophilia B IV InTrial Late 2021 Yes No
PW-4142 (T-111) nalbuphine ER Trevi Therapeutics/ Endo opioid agonist/ antagonist Prurigo nodularis PO InTrial Late 2021 No No
insulin-like growth factor 1 Rett syndrome/ Fragile X NNZ-2566 trofinetide Neuren IV/PO InTrial Late 2021 Yes Yes (IGF-1) derivative syndrome/ Brain injury
GSK-2696274 (OTL-200) GSK-2696274 (OTL-200) GlaxoSmithKline gene therapy Leukodystrophy IV InTrial Late 2021 Yes Yes
IM = intramuscular, INH = inhalation, INJ = injection, IUD = intrauterine device, IV = intravenous, OP = ophthalmic, PO = oral, SC = subcutaneous, SL = sublingual, SPR = spray, TOP = topical, VG = vaginal, NSCLC = Non-small cell lung cancer, COPD = Chronic Obstructive Pulmonary Disease
CastiaRx.com // p: 866.516.2121 22