Brand Pipeline Forecast 4th 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
RVT-802 RVT-802 Enzyvant/Roivant Tissue-based therapy Congenital athymia Implant Filed NDA 12/2019 Yes Yes
Zimhi naloxone Adamis opioid antagonist Opioid dependence IM Filed NDA 12/2019 No No
calcitonin gene-related MK-1602 (AGN-241689) ubrogepant Allergan/ Merck peptide (CGRP) receptor Acute migraines PO Filed NDA 12/2019 No No antagonist
IDP-123 IDP-123 Bausch Health retinoid Acne TOP Filed NDA 12/22/2019 No No
Brinavess 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 lumateperone Intra-Cellular Therapies antipsychotic Schizophrenia PO Filed NDA 12/27/2019 No No
HIV integrase inhibitor/ cabotegravir (long-acting)/ non-nucleoside reverse TMC-278-LA ViiV Healthcare HIV IM Filed NDA 12/29/2019 Yes No rilpivirine (long- acting) transcriptase inhibitor (NNRTI)
S-265744 (S/GSK- 1265744) cabotegravir ViiV Healthcare HIV integrase inhibitor HIV PO Filed NDA 12/29/2019 Yes No
NRL-1 diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 2H2019 No Yes
2020 Possible Launch Date
integrin receptor 12/2019 - Entyvio (SC formulation) vedolizumab Takeda Ulcerative colitis SC Filed sBLA Yes No antagonist 1/2020
methyltransferase EZH2 E-7438 (EPZ- 6438) tazemetostat Epizyme/ Eisai Sarcoma PO Filed NDA 1/23/2020 Yes Yes inhibitor
CastiaRx.com // p: 866.516.2121 1 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
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
AR-101 AR-101 Aimmune peanut protein capsule Peanut allergy PO Filed BLA 1/2020 Yes No
selective KIT and PDGFRa Gastrointestinal stromal BLU-285 avapritinib Blueprint Medicines PO Filed NDA 2/14/2020 Yes Yes inhibitor tumors
ethinyl estradiol/ hormonal combination Twirla Agile Therapeutics Pregnancy prevention TOP Filed NDA 2/16/2020 No No levonorgestrel contraceptive
calcitonin gene-related BMS-927711 (BHV-3000) rimegepant sulfate Biohaven peptide (CGRP) receptor Acute migraines PO Filed NDA 2/20/2020 No No antagonist
calcitonin gene-related ALD-403 eptinezumab Alder peptide (CGRP) receptor Migraine prevention IV Filed BLA 2/21/2020 No No antagonist
ETC-1002 bempedoic acid Esperion Therapeutics ATP citrate lyase inhibitor Hypercholesterolemia PO Filed NDA 2/21/2020 No No
ATP citrate lyase inhibitor/ ETC-1002/ bempedoic acid/ ezetimibe Esperion Therapeutics cholesterol absorption Hypercholesterolemia PO Filed NDA 2/26/2020 No No ezetimibe inhibitor
dopamine receptor APD-421 amisulpride Acacia Nausea/ vomiting IV Filed NDA 2/26/2020 No No antagonist
insulin-like growth factor 1 RV-001 (Roche- 1, R-1507) teprotumumab Horizon Therapeutics Thyroid eye disease IV Filed BLA 3/8/2020 Yes Yes (IGF-1) receptor antagonist
ITCA-650 exenatide sustained- glucagon-like peptide-1 (sustained release Intarcia Diabetes mellitus SC implant Filed NDA 3/9/2020 No No release (GLP-1) receptor agonist exenatide)
VS-EBOV (rVSV- EBOV; rVSV- ZEBOV Merck/ NewLink Genetics vaccine Ebola IM Filed BLA 3/14/2020 Yes No ZEBOV-GP)
CastiaRx.com // p: 866.516.2121 2 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
naloxone naloxone Insys Therapeutics opioid antagonist Opioid dependence Intranasal Filed NDA 3/15/2020 No No
ASG-22M6E enfortumab vedotin Astellas/ Seattle Genetics nectin-4 antagonist Bladder cancer IV Filed BLA 3/15/2020 Yes No
ET-105 lamotrigine Eton anticonvulsant Epilepsy PO Filed NDA 3/17/2020 No No
sphingosine 1-phosphate 1 ozanimod ozanimod Celgene (S1PR1) and 5 (S1PR5) Multiple sclerosis PO Filed NDA 3/25/2020 Yes No receptor modulator
farnesoid X receptor (FXR) Nonalcoholic obeticholic acid obeticholic acid Intercept Pharmaceuticals PO Filed NDA 3/26/2020 Yes No agonist steatohepatitis
IntelGenx / Red Hill Rizaport (VersaFilm) rizatriptan triptans Acute migraines PO Filed NDA 3/26/2020 No No Biopharma
anesthetic/ Nonsteroidal HTX-011 bupivacaine/ meloxicam Heron Therapeutics Anti-inflammatory Drug Pain Instillation Filed NDA 3/26/2020 No No (NSAID)
Sun Pharma Advanced paclitaxel injection Breast Cancer; Lung SPARC-1028 Research Company taxane IV Filed NDA 1Q2020 No No concentrate for suspension Cancer; Pancreatic Cancer (SPARC)
SABER- Posidur Novartis/ Durect local anesthetic Pain SC Filed NDA 1Q2020 No No bupivacaine CR
aldosterone synthase LCI-699 osilodrostat Novartis Cushing's syndrome PO Filed NDA 1Q2020 No Yes inhibitor
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
bimatoprost sustained bimatoprost sustained Allergan prostaglandin agonist Glaucoma Implant Filed NDA 4/1/2020 No No release release
CNS-7056 remimazolam Cosmo benzodiazepine Procedural sedation IV Filed NDA 4/3/2020 Yes No
CastiaRx.com // p: 866.516.2121 3 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
meningococcal polysaccharide (serogroups Men Quad TT Sanofi antibacterial meninococcus/ tetanus IM Filed BLA 4/25/2020 No No A, C, Y, and W135) tetanus toxoid conjugate vaccine
catechol-O- Neurocrine Biosciences/ Ongentys opicapone methyltransferase (COMT) Parkinson's 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
HER2-targeting antibody- DS-8201 trastuzumab deruxtecan Daiichi Sankyo Breast cancer IV Filed BLA 4/29/2020 Yes No drug conjugate
Multiple myeloma/ Acute isatuximab isatuximab Sanofi/ ImmunoGen CD38 antagonist lymphoblastic leukemia or IV Filed BLA 4/30/2020 Yes Yes lymphoblastic lymphoma selective MEK kinase 4/2020 – selumetinib selumetinib AstraZeneca/ Merck Neurofibromatosis PO Filed NDA Yes Yes inhibitor 5/2020
SEP-225289 (DSP-225289, Sumitomo Dainippon/ dasotraline triple reuptake inhibitor Eating disorders PO Filed NDA 5/14/2020 No No SEP-289) Sunovion
selective FGFR1/2/3 INCB-54828 pemigatinib Incyte Biliary tract cancer PO Filed NDA 5/2020 Yes Yes inhibitor
FMX-103 minocycline Foamix tetracyclines Rosacea TOP Filed NDA 6/2/2020 No No
morpholino antisense Duchenne muscular NS-065 viltolarsen Nippon Shinyaku IV Filed BLA 6/2/2020 Yes Yes oligonucleotide dystrophy
Tentative Bafiertam monomethyl fumarate Banner Life Sciences Nrf2 pathway activator Multiple sclerosis PO 6/20/2020 Yes No Approval
Age-related macular 6/2020 – abicipar pegol abicipar pegol Allergan VEGF-A inhibitor Intravitreal Filed BLA Yes No degeneration 7/2020
Neuromyelitis optica 6/13/2020 - MEDI-551 inebilizumab Viela Bio CD-19 antagonist IV Filed BLA Yes Yes spectrum disorder 7/13/2020
CastiaRx.com // p: 866.516.2121 4 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
EVK-001 metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal CRL 2Q2020 No No
osmotic gradient enhancer; Bronchitol mannitol Pharmaxis Cystic fibrosis INH CRL 2Q2020 No Yes mucus clearance enhancer
Rexista XR oxycodone ER IntelliPharmaCeutics opioid agonist Pain PO Not Approved 1H2020 No No
insulin glargine insulin glargine Mylan/ Biocon Long-acting insulin Diabetes mellitus SC CRL 1H2020 No No
RS7-SN-38 antibody-drug IMMU-132 sacituzumab govitecan Immunomedics Breast cancer IV CRL 1H2020 Yes No conjugate
NKTR-181 NKTR-181 Nektar opioid agonist Pain PO Not Approved 1H2020 No No
morpholino antisense Duchenne muscular SRP-4045 casimersen Sarepta IV InTrial Mid-2020 Yes Yes oligonucleotide dystrophy
Contepo fosfomycin Nabriva Therapeutics cell wall inhibitor Bacterial infections IV CRL Mid-2020 Yes No
RG-7916 risdiplam Roche/ PTC Therapeutics SMN2 splicing modifier Spinal muscular atrophy PO InTrial Mid-2020 Yes Yes
Apealea (Paclical) paclitaxel Oasmia taxane Ovarian cancer IV InTrial Mid-2020 Yes Yes
Diffuse large B-cell phosphoinositide-3 kinase TGR-1202 umbralisib TG Therapeutics/ Rhizen lymphoma/ Chronic PO InTrial Mid-2020 Yes Yes (PI3K) delta inhibitor lymphocytic leukemia
Mesoblast/ JCR/ Prochymal remestemcel-L Mallinckrodt/ Osiris mesenchymal stem cells Graft vs. Host disease IV InTrial Mid-2020 Yes Yes Therapeutics
MOR-208 (MOR-00208, Diffuse large B-cell tafasitamab MorphoSys/ Xencor CD-19 antagonist IV InTrial Mid-2020 Yes Yes XmAB-5574) lymphoma
CastiaRx.com // p: 866.516.2121 5 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Solid tumors; non- small LOXO-292 selpercatinib Eli Lilly/ Loxo Oncology RET inhibitor cell lung cancer; thyroid PO InTrial Mid-2020 Yes No cancer
Amphora Amphora Evofem Biosciences spermicidal agent Pregnancy prevention VG CRL Mid-2020 No No
C-C chemokine receptor 5 PRO-140 leronlimab CytoDyn HIV; Graft vs. host disease SC InTrial Mid-2020 Yes Yes (CCR5) antagonist
long-acting beta 2 adrenergic receptor indacaterol/ agonist (LABA)/ long- QVM-149 glycopyrronium bromide/ Novartis/ Sosei Asthma INH InTrial Mid-2020 No No acting muscarinic receptor mometasone furoate antagonist (LAMA)/ corticosteroid
chimeric antigen receptor Diffuse large B-cell JCAR-017 lisocabtagene maraleucel Juno/ Celgene IV InTrial Mid-2020 Yes Yes (CAR) T cell therapy lymphoma
mometasone furoate/ corticosteroid/ GSP-301 Glenmark Allergic rhinitis Intranasal CRL Mid-2020 No No olopatadine HCl antihistamine
lurbinectidin PharmaMar/ Myriad Zepsyre alkylating agent Small cell lung cancer IV InTrial Mid-2020 Yes Yes (lurbinectedin) Genetics
MitoGel mitomycin C UroGen alkylating agent Bladder cancer Intravesical InTrial Mid-2020 No Yes
3-F8 (Hu-3F8) naxitamab Y-mAbs Therapeutics GD2 antagonist Neuroblastoma IV InTrial Mid-2020 Yes Yes
lentiviral beta- globin gene Zynteglo (LentiGlobin) Bluebird Bio gene therapy Beta-thalassemia IV InTrial Mid-2020 Yes Yes transfer
CastiaRx.com // p: 866.516.2121 6 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Hutchinson-Gilford Progeria Syndrome (HGPS EBP-994 (rEBP- 994) lonafarnib Eiger Biopharmaceuticals prenylation inhibitor or progeria) and progeroid PO InTrial Mid-2020 Yes Yes laminopathies; Hepatitis D (HDV)
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)
Fintepla fenfluramine Zogenix serotonin receptor agonist Dravet syndrome PO Filed NDA 7/24/2020 Yes Yes
calcipotriene/ vitamin D analog/ MC2-01 MC2 Therapeutics Psoriasis TOP Filed NDA 7/24/2020 No No betamethasone corticosteroid
Ultragenyx/ Baylor Glucose transport type 1 UX-007 triheptanoin Research Institute/ medium chain fatty acid PO Filed NDA 7/31/2020 Yes Yes deficiency syndrome Uniquest
Viaskin Peanut Viaskin Peanut DBV Technologies Immunotherapy Peanut allergy TOP Filed BLA 8/5/2020 No No
TRC-101 veverimer Tricida carrier protein modulator Chronic kidney disease PO Filed NDA 8/22/2020 Yes No
Winlevi clascoterone Cassiopea androgen antagonist Acne vulgaris TOP Filed NDA 8/27/2020 No No
interleukin-6 (IL-6) 8/2020 – SA-237 (RG- 6168) satralizumab Roche/ Chugai Neuromyelitis optica SC Filed BLA Yes Yes monoclonal antibody 9/2020
collagenase clostridium collagenase clostridium Endo protease enzyme Cellulite SC Filed BLA 9/6/2020 Yes No histolyticum histolyticum
CastiaRx.com // p: 866.516.2121 7 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
VP-102 VP-102 Verrica antiviral Molluscum TOP Filed NDA 9/16/2020 No No
NNC-0195- 0092 (NN- recombinant human Growth hormone somapacitan Novo Nordisk SC Filed BLA 9/21/2020 Yes No 8640) growth hormone (rhGH) deficiency
LY-900014 (URLi) insulin lispro Eli Lilly insulins Diabetes mellitus SC Filed BLA 3Q2020 No No
valoctocogene BMN-270 BioMarin gene therapy Hemophilia IV InTrial 3Q2020 Yes Yes roxaparvovec
non-nucleoside reverse Tentative efavirenz efavirenz Micro Labs transcriptase inhibitor HIV PO 3Q2020 Yes No Approval (NNRTI)
GlaxoSmithKline/ Seattle anti-BCMA antibody-drug GSK-2857916 belantamab mafodotin Multiple myeloma SC InTrial 3Q2020 Yes Yes Genetics conjugate
delta-9- tetrahydrocannab PPP-001 PhytoPain Pharma cannabinoid product Pain INH InTrial 3Q2020 Yes Yes inol/ cannabidiol
BCX-7353 BCX-7353 BioCryst kallikrein inhibitor Hereditary angioedema PO InTrial 3Q2020 Yes Yes
granulocyte colony- SPI-2012 eflapegrastim Spectrum/ Hanmi Neutropenia SC Filed BLA 10/25/2020 Yes No stimulating factor (GCSF)
opioid receptor agonist Tentative CAM-2038 buprenorphine Camurus/ Braeburn Opioid use disorder/ Pain SC 11/1/2020 Yes No (partial) Approval
selective norepinephrine Attention deficit SPN-812 SPN-812 Supernus PO Filed NDA 11/11/2020 No No reuptake inhibitor hyperactivity disorder
CastiaRx.com // p: 866.516.2121 8 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Multiple myeloma/ Non- alkylating agent/ DNA Melflufen (Ygalo) melphalan- flufenamide Oncopeptides AB small cell lung cancer/ IV InTrial 4Q2020 No Yes synthesis inhibitor Ovarian cancer
PDGFR-alpha kinase Gastrointestinal stromal DCC-2618 ripretinib Deciphera PO InTrial 4Q2020 Yes Yes inhibitor tumors
proprotein convertase The Medicines Company/ ALN-PCSsc (PCSK9si) inclisiran subtilisin/kexin 9 (PCSK- Hyperlipidemia SC InTrial 4Q2020 Yes Yes Alnylam 9) inhibitor
Seattle Genetics/ Array ErbB-2 (Her-2/neu) ARRY-380 (ONT-380) tucatinib Breast cancer PO InTrial 4Q2020 Yes Yes BioPharma inhibitor
BLU-667 pralsetinib Blueprint Medicines RET inhibitor Non-small cell lung cancer PO InTrial 4Q2020 Yes Yes
janus associated kinase-1 GLPG-0634 filgotinib Gilead/ Galapagos Rheumatoid arthritis PO InTrial 4Q2020 Yes No (JAK) inhibitor
Pulmonary arterial LIQ-861 treprostinil Liquidia Technologies prostacyclin analog INH InTrial 4Q2020 Yes No hypertension
ofatumumab (OMB-157) ofatumumab Novartis CD20 monoclonal antibody Multiple sclerosis SC InTrial 4Q2020 Yes No
Infacort hydrocortisone Diurnal Group corticosteroid Adrenal insufficiency PO InTrial 4Q2020 No Yes
gonadotropin-releasing Myovant Sciences/ Roivant Uterine fibroids/ TAK-385 TAK-385 hormone (GnRH) receptor PO InTrial 4Q2020 Yes No Sciences/ Takeda Endometriosis antagonist
tramadol tramadol Avenue Therapeutics opioid receptor agonist Pain IV InTrial 4Q2020 No No
CastiaRx.com // p: 866.516.2121 9 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
dehydrated human Plantar fasciitis/ Achilles AmnioFix amnion/chorion MiMedx amniotic tissue membrane INJ InTrial 4Q2020 Yes No tendonitis/ Osteoarthritis membrane (dHACM)
Estelle estetrol/ drospirenone Mithra/ Fuji/ Zhejian Xianju estrogen receptor agonist Pregnancy prevention PO/SL InTrial 4Q2020 No No
Qtrypta zolmitriptan Zosano triptans Acute migraines TOP InTrial 4Q2020 No No
selective retinoic acid Fibrodysplasia ossificans R-667 (RG-667) palovarotene Clementia/ Roche receptor agonist (RAR- PO InTrial 4Q2020 Yes Yes progressiva (FOP) gamma)
dopamine receptor Schizophrenia/ Bipolar ALKS-3831 olanzapine/ samidorphan Alkermes antagonist/ opioid PO InTrial 4Q2020 No No disorder receptor antagonist
REGN-EB3 REGN-EB3 Regeneron anti-Ebola virus Ebola IV InTrial 4Q2020 Yes Yes
hypoxia-inducible factor FG-4592 roxadustat FibroGen/ AstraZeneca prolyl hydroxylase Anemia PO InTrial 2H2020 Yes No (HIF-PHI)
Laboratorios Doria risperidone atypical antipsychotic Schizophrenia IM InTrial 2H2020 Yes No Farmacéuticos Rovi
Acute respiratory distress Traumakine interferon-beta - 1a Faron/ Maruishi interferon IV InTrial 2H2020 Yes No syndrome
NX-1207 (NYM-4805, REC Benign prostatic fexapotide triflutate Nymox pro-apoptotic Intratumoral InTrial 2H2020 Yes No 0482) hyperplasia
CastiaRx.com // p: 866.516.2121 10 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
chimeric antigen receptor bb-2121 idecabtagene vicluecel Celgene/ Bluebird Bio Multiple myeloma IV InTrial 2H2020 Yes Yes (CAR) T cell therapy
131I-8H9 omburtamab Y-mAbs Therapeutics B7-H3 antagonist Brain cancer Undisclosed InTrial 2H2020 Yes Yes
IdeS imlifidase Hansa Medical bacterial enzyme Kidney transplant IV InTrial 2H2020 Yes Yes
Otsuka/ Astex nucleoside metabolic ASTX-727 decitabine and E- 7727 Myelodysplastic syndrome PO InTrial 2H2020 Yes Yes Pharmaceuticals inhibitor
Sci-B-Vac hepatitis B vaccine VBI Vaccines vaccine Hepatitis B IM InTrial 2H2020 No No
LJPC-0118 LJPC-0118 La Jolla Pharmaceutical protozoacide Malaria Undisclosed InTrial 2H2020 No No
BMS-663068 fostemsavir Bristol-Myers Squibb HIV attachment inhibitor HIV PO InTrial 2H2020 Yes No
Zeftera ceftobiprole Basilea cephalosporin antibiotic Bacterial infections IV InTrial 2H2020 Yes No
Aromatic L-amino acid AGIL-AADC AGIL-AADC Agilis Biotherapeutics gene therapy Intracerebral InTrial 2H2020 Yes Yes decarboxylase deficiency
chimeric antigen receptor KTE-X19 KTE-X19 Gilead Mantle cell lymphoma IV InTrial 2H2020 Yes Yes (CAR) T cell therapy
CLS-1001 triamcinolone acetonide Clearside corticosteroid Macular edema intraocular/ subretinal CRL 2H2020 Yes No
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
CastiaRx.com // p: 866.516.2121 11 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
KPI-121 0.25% loteprednol etabonate Kala corticosteroid Dry eyes OP CRL 2H2020 No No
PharmaEssentia/ AOP ropeginterfero n alfa-2b ropeginterferon alfa-2b interferon Polycythemia vera SC InTrial 2H2020 Yes Yes Orphan
D-threo- methylphenidate Attention deficit KP-415 KemPharm CNS stimulant PO InTrial 2H2020 No No controlled-release hyperactivity disorder
iodine I 131 monoclonal anti-CD45 monoclonal Acute myeloid leukemia/ Iomab-B Actinium IV InTrial 2H2020 Yes Yes antibody BC8 antibody Myelodysplastic syndrome
FLT-3 receptor tyrosine quizartinib quizartinib Daiichi Sankyo Acute myeloid leukemia PO CRL 2H2020 Yes Yes kinase inhibitor
dexamethasone phosphate EGP-437 EyeGate corticosteroid Uveitis OP InTrial 2H2020 Yes No (iontophoretic)
Libervant diazepam Aquestive Therapeutics benzodiazepine Seizures SL InTrial 2H2020 No Yes
TRV-130 oliceridine Trevena opioid receptor agonist Pain IV CRL 2H2020 No No
Niemann-Pick Disease/ Sporadic Inclusion Body arimoclomol arimoclomol Orphazyme cytoprotectives PO InTrial 2H2020 Yes Yes Myositis/ Amyotrophic lateral sclerosis
Mycapssa (Octreolin) octreotide Chiasma somatostatin analog Acromegaly PO CRL 2H2020 Yes Yes
End stage renal diease/ human elastase Peripheral artery disease/ PRT-201 vonapanitase Proteon Therapeutics TOP InTrial 2H2020 Yes Yes (recombinant) Vascular access in hemodialysis
PRX-102 alpha galactosidase Protalix enzyme replacement Fabry disease IV InTrial 2H2020 Yes No
CastiaRx.com // p: 866.516.2121 12 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
INCB-028060 (INC-280) capmatinib Novartis/ Incyte cMET inhibitor Non-small cell lung cancer PO InTrial 2H2020 Yes Yes
ET-103 levothyroxine Eton Pharmaceuticals L-thyroxine Hypothyroidism PO InTrial 2H2020 No No
anti-ECAM exotoxin A Vicinium (VB-4- 845) oportuzumab monatox Eleven Biotherapeutics Bladder cancer Intravesical InTrial 2H2020 Yes No fusion protein
RT-002 daxibotulinumtoxi nA Revance Therapeutics botulinum toxins Glabellar lines (frown lines) IM InTrial 2H2020 Yes Yes
nonsteroidal anti- N-1539 meloxicam Recro Pharma/ Alkermes Pain IV CRL 2020 Yes No inflammatory drug (NSAID)
indacaterol maleate/ long-acting beta 2 agonist/ QMF-149 Novartis/ Merck Asthma INH InTrial 2020 No No mometasone furoate corticosteroid
dopamine precursor/ dopa- ND-0612L levodopa/ carbidopa NeuroDerm Parkinson's disease SC InTrial 2020 Yes No decarboxylase inhibitor
ornithine decarboxylase Familial adenomatous CPP-1X/ Cancer Prevention inhibitor/ non-steroidal eflornithine/ sulindac polyposis/ Colorectal PO InTrial 2020 Yes Yes sulindac (DFMO) Pharma/ Zeria anti-inflammatory drug cancer (NSAID)
Zalviso sufentanil, ARX-01 AcelRx opioid analgesic Pain SL CRL 2020 No No
mycolic acid biosynthesis Deltyba delamanid Otsuka Tuberculosis PO InTrial 2020 No No inhibitor
Pedmark (STS) sodium thiosulfate Fennec reducing agent Hearing loss IV InTrial 2020 Yes Yes
dopamine precursor/ dopa- ND-0612H levodopa/ carbidopa NeuroDerm Parkinson's disease SC InTrial 2020 Yes No decarboxylase inhibitor
DS-200 DS-200 Eton undisclosed Ophthalmological disease SC InTrial 2020 No No
CastiaRx.com // p: 866.516.2121 13 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
ELI-200 oxycodone/ naltrexone Elite opioid agonist Pain PO CRL 2020 No No
astodrimer sodium (SPL- VivaGel Starpharma viral attachment inhibitor Bacterial infections VG CRL 2020 No No 7013) Blepharitis/ Ocular Dexasite dexamethasone InSite Vision corticosteroid TOP InTrial 2020 No No inflammation Chronic lymphocytic ublituximab (LFB-R603, leukemia/ Small cell TG20, TGTX- 1101, TG- CD-20 monoclonal ublituximab TG Therapeutics lymphocytic lymphoma/ IV InTrial 2020 Yes Yes 1101, antibody Mantle cell lymphoma/ Utuxin) Multiple sclerosis
CCP-08 CCP-08 Tris Pharma undisclosed Viral rhinitis PO CRL 2020 No No
autologous chondrocyte autologous chondrocyte NeoCart Histogenics/ Purpose Joint repair Undisclosed InTrial 2020 Yes No tissue implant tissue implant
APN-311 dinutuximab beta EUSA Pharma disialoganglioside Neuroblastoma SC InTrial 2020 Yes Yes
alpha-adrenergic Benign prostatic tamsulosin DRS tamsulosin delayed-release Veru PO InTrial 2020 No No antagonist hyperplasia
Oralair Mites (Actair) dust mite peptide Stallergenes/ Shionogi vaccine Dust mite allergic rhinitis SL InTrial 2020 Yes No
Travivo gepirone ER GSK/Fabre-Kramer 5-HT-1A receptor agonist Major depressive disorder PO CRL 2020 No No
MNK-812 oxycodone Mallinckrodt 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
phosphodiesterase-5 (PDE- tadalafil VersaFilm tadalafil VersaFilm IntelGenx Erectile dysfunction PO Filed NDA 2020 Yes No 5) inhibitor
CastiaRx.com // p: 866.516.2121 14 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Leukocyte Interleukin (CS- Head and Neck cancer/ Multikine CEL-SCI immunomodulator SC InTrial 2020 Yes Yes 001P3) Squamous cell carcinoma
phosphodiesterase-5 (PDE- APC-8000 tadalafil Adamis Erectile dysfunction PO CRL 2020 Yes No 5) inhibitor
Corplex donepezil donepezil Corium International anticholinergic Alzheimer's disease TOP InTrial Late 2020 No No
Acute myeloid leukemia/ CC-486 azacitidine Celgene DNA methylation inhibitor Myelodysplastic PO InTrial Late 2020 Yes Yes syndromes
Non-cystic fibrosis Linhaliq ciprofloxacin Aradigm/ Grifols fluoroquinolone bronchiectasis/ Cystic INH CRL Late 2020 Yes Yes fibrosis
Acute myeloid leukemia/ Nedd 8 Activating Enzyme Chronic myelogenous MLN-4924 (TAK-92) pevonedistat Takeda PO InTrial Late 2020 Yes No (NAE) antagonist leukemia/ Myelodysplastic syndrome
neurotrophic tyrosine kinase receptor type 1 tanezumab tanezumab Pfizer/ Eli Lilly Osteoarthritis/ Pain IV/SC InTrial Late 2020 Yes No (TrkA) antagonist (monoclonal antibody)
complement C1s BIVV-009 (TNT- 009) sutimlimab Sanofi Cold agglutinin disease IV InTrial Late 2020 Yes Yes subcomponent inhibitor
Orphan Therapeutics/ Lucassin terlipressin V-1 (vasopressin) agonist Hepato-renal syndrome IV CRL Late 2020 Yes Yes Ikaria
tetrahydrofolate iclaprim iclaprim Motif Bio Bacterial infections IV CRL Late 2020 Yes Yes dehydrogenase inhibitor
CastiaRx.com // p: 866.516.2121 15 Brand Pipeline Forecast 4th 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-4053 golodirsen Sarepta IV CRL Late 2020 Yes Yes oligonucleotide dystrophy
NS-2 (ALDX- 1E1, ALDX-1E2, Allergic conjunctivitis/ Dry reproxalap Aldeyra Therapeutics aldehyde antagonist OP InTrial Late 2020 No No ADX-102) eyes
Ryplazim human plasminogen ProMetic/ Hematech plasminogen Plasminogen deficiency IV CRL Late 2020 Yes Yes
Hematopoietic stem cell anti-MASP-2 monoclonal transplant- associated OMS-721 narsoplimab Omeros IV/SC InTrial Late 2020 Yes Yes antibody thrombotic microangiopathy
Cerebral adreno- Lenti-D elivaldogene tavalentivec Bluebird Bio gene therapy IV InTrial Late 2020 Yes Yes myeloneuropathy
CD-20 monoclonal Chronic lymphocytic antibody/ leukemia/ Diffuse large B- TG-1303 ublituximab/ TGR- 1202 TG Therapeutics IV/PO InTrial Late 2020 Yes Yes phosphoinositide-3 kinase cell lymphoma/ Non- (PI3K) delta inhibitor Hodgkin lymphoma
MVA-MUC1- IL2 TG-4010 Transgene vaccine Non-small cell lung cancer SC InTrial Late 2020 No No
SHP-621 budesonide Shire corticosteroid Eosinophilic esophagitis PO InTrial Late 2020 Yes Yes
HuMax-TF ADC tisotumab vedotin Genmab/ Seattle Genetics tissue factor antibody Solid tumors Undisclosed InTrial Late 2020 Yes No
C-type natriuretic peptide BMN-111 vosoritide (vasoritide) BioMarin/ Chugai Achondroplasia SC InTrial Late 2020 Yes Yes (CNP) analog
TSR-042 dostarlimab AnaptysBio PD-1 checkpoint inhibitor Endometrial cancer IV InTrial Late 2020 Yes No
sodium oxybate extended- JZP-258 Jazz dopamine receptor agonist Narcolepsy PO InTrial Late 2020 Yes No release
gene transcription Duchenne muscular Translarna ataluren PTC Therapeutics PO CRL Late 2020 Yes Yes modulator dystrophy
CastiaRx.com // p: 866.516.2121 16 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
corticosteroid/ long- acting budesonide/ muscarinic receptor Chronic obstructive BGF-MDI (PT- 010) glycopyrronium/ AstraZeneca antagonist (LAMA)/ long- INH CRL Late 2020 No No pulmonary disease formoterol acting beta 2 adrenergic receptor agonist (LABA)
HM-30181A/ P-glycoprotein pump Oraxol Athenex Breast cancer PO InTrial Late 2020 Yes Yes paclitaxel inhibitor/ taxane
melanocortin 4 receptor Rare genetic disorders of BIM-22493 (RM-493) setmelanotide Rhythm/ Camurus/ Ipsen SC InTrial Late 2020 Yes Yes (MC4R) agonist obesity
sphingosine 1 phosphate RG-3477 (ACT- 128800) ponesimod Johnson & Johnson Multiple sclerosis PO InTrial Late 2020 Yes No receptor agonist
2021 Possible Launch Date
glycolate oxidase ALNG-01 (ALN- G-01) lumasiran Alnylam Hyperoxaluria Intranasal InTrial 1Q2021 Yes Yes antagonist
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
amyloid beta-protein BIIB-037 aducanumab Biogen Idec/ Eisai Alzheimer's disease IV InTrial 1Q2021 Yes No inhibitor
Src kinase and tubulin KX-01 (KX2- 391) tirbanibulin Athenex Actinic keratosis PO InTrial 1Q2021 Yes No inhibitor
ZP-4207 (ZP- GA-1) dasiglucagon Zealand Pharma glucagon analog Diabetes mellitus SC InTrial 1Q2021 No Yes
Furoscix furosemide scPharmaceuticals diuretic Heart failure SC CRL 1Q2021 Yes No
Sun Pharma Advanced SDP-037, SDN- 037 SDP-037, SDN-037 Research Company Corticosteroid Ocular inflammation/pain OP InTrial 2Q2021 No No (SPARC)
CastiaRx.com // p: 866.516.2121 17 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
SCY-078 ibrexafungerp Scynexis glucan synthase inhibitors Fungal infections IV/PO InTrial 1H2021 No Yes
Short stature/ growth ACP-001 TransCon Growth Hormone Ascendis growth hormone prodrug SC InTrial 1H2021 Yes No hormone deficiency
RGN-259 (GBT- 201; RGN- Neurotrophic keratitis/ Dry thymosin beta 4 RegeneRx actin regulating peptide OP InTrial 1H2021 No Yes 352) eyes
protein absorption CM-AT CM-AT Curemark Autism PO InTrial 1H2021 Yes No enhancer
selective peroxisome Non-alcoholic GFT-505 elafibranor Genfit proliferator-activated steatohepatitis/ Primary PO InTrial 1H2021 Yes No receptor (PPAR) modulator biliary cirrhosis
MediWound/ BL&H/ peptide hydrolase NexoBrid bromelain Burns/ Skin injury TOP InTrial 1H2021 No Yes CrystalGenomics/ Kaken replacement agent
PDR-001 PDR-001 Novartis PD-1 checkpoint inhibitor Melanoma IV InTrial 1H2021 Yes No
C5a receptor (C5aR) CCX-168 avacopan ChemoCentryx/ Galencia Vasculitis PO InTrial 1H2021 Yes Yes antagonist
StrataGraft Skin Tissue StrataGraft Skin Tissue Mallinckrodt autologous skin tissue Burn injury TOP InTrial 1H2021 Yes Yes
tumor vascular disrupting NPI-2358 plinabulin BeyondSpring Neutropenia IV InTrial 1H2021 Yes No agent
Niemann-Pick disease type GZ-402665 olipudase alfa Sanofi sphingomyelinase IV InTrial Mid-2021 Yes Yes B
X-linked myotubular AT-132 (AAV8- MTM1) AT-132 (AAV8- MTM1) Audentes Therapeutics gene therapy IV InTrial Mid-2021 Yes Yes myopathy
GZ-402666 (NeoGAA) avalglucosidase alfa Sanofi enzyme therapy Pompe disease IV InTrial Mid-2021 Yes No
CastiaRx.com // p: 866.516.2121 18 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
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 infection
histone deacetylase entinostat entinostat Syndax Breast cancer PO InTrial Mid-2021 Yes No (HDAC) inhibitor
Diffuse large B-cell ADCT-402 loncastuximab tesirine ADC Therapeutics antibody drug conjugate IV InTrial Mid-2021 Yes Yes lymphoma
phosphodiesterase type 5 Benign prostatic TadFin tadalafil and finasteride Veru inhibitor /5-alpha- PO InTrial Mid-2021 No No hyperplasia reductase inhibitor
non-steroidal anti- AXS-07 meloxicam/rizatri ptan Axsome Therapeutics Migraine PO InTrial Mid-2021 No No inflammatory drug/triptan
ALN-APC (ALN- AT3) fitusiran Alnylam/ Sanofi RNAi therapeutic Hemophilia SC InTrial Mid-2021 Yes Yes
Duchenne muscular WVE-210201 suvodirsen Wave Life Sciences oligonucleotide IV InTrial Mid-2021 Yes Yes dystrophy
Sun Pharma Advanced PDP-716 brimonidine Research Company alpha-2 agonist Glaucoma OP InTrial 3Q2021 No No (SPARC)
MacroGenics/ Provention PRV-031 teplizumab CD3 antigen inhibitor Diabetes mellitus IV InTrial 4Q2021 Yes Yes Bio
C-C chemokine receptor 5 Tobira Therapeutics/ Non-alcoholic TBR-652 cenicriviroc (CCR5) and receptor 2 PO InTrial 4Q2021 Yes No Takeda steatohepatitis antagonist
CastiaRx.com // p: 866.516.2121 19 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
selective alpha 2a receptor Schizophrenia and bipolar BXCL-501 dexmedetomidine BioXcel Therapeutics PO InTrial 2H2021 No No agonist disorder
Psoriasis/ Psoriatic interleukin-17 (IL-17) arthritis/ Ankylosing UCB-4940 (CDP-4940) bimekizumab UCB IV InTrial 2H2021 Yes No receptor inhibitor spondylitis/ Rheumatoid arthritis
177Lu-PSMA- Lutetium Endocyte Radiopharmaceutical Prostate cancer IV InTrial 2H2021 Yes No 617
nicotinic acetylcholine OS-01 OC-01 Oyster Point Pharma Dry eye disease Intranasal InTrial 2H2021 No No receptor (nAChR) agonist
SHP-647 SHP-647 Shire MAdCAM-1 antagonist Irritable bowel disease IV/SC InTrial 2H2021 Yes Yes
IDP-124 pimecrolimus Bausch Health calcineurin Inhibitor Atopic dermatitis TOP InTrial 2H2021 No No
glatiramer acetate long- glatiramer acetate depot Mylan/ Mapi Pharma immunosuppressant Multiple sclerosis IM InTrial 2H2021 Yes No acting
ROCK2 (Rho-associated KD-025 KD-025 Kadmon coiled-coiled kinase 2) Graft vs. Host disease PO InTrial 2H2021 No Yes inhibitor
dextromethorpha n/ N-methyl-D-aspartate Treatment-resistant AXS-05 Axsome PO InTrial 2H2021 No No bupropion (NMDA) antagonist depression
dexamethasone sustained- Otividex Otonomy corticosteroid Meniere's disease Intratympanic InTrial 2H2021 Yes No release
interferon receptor Systemic lupus MEDI-546 anifrolumab AstraZeneca/ BMS IV InTrial 2H2021 Yes No antagonist erythematosus
CastiaRx.com // p: 866.516.2121 20 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
tumor infiltrating LN-145 lifileucel Iovance Biotherapeutics Cervical Cancer IV InTrial 2H2021 Yes No lymphocyte
POD- INP-104 dihydroergotamin e Impel/ 3M ergot derivative Acute migraines Intranasal InTrial 2H2021 No No mesylate (POD- DHE)
Attention deficit SPN-810 molindone Supernus atypical antipsychotic PO InTrial 2H2021 No No hyperactivity disorder
GS-010 GS-010 GenSight Biologics gene therapy Optic neuropathy Intraocular InTrial 2H2021 Yes Yes
TWIN (S6G5T- 1; S6G5T-3) benzoyl peroxide/ tretinoin Sol-Gel Technologies retinoid Acne vulgaris TOP InTrial 2H2021 No No
digitalis-like factor AMAG-423 digoxin immune fab (DIF) AMAG/ Velo Preeclampsia IV InTrial 2H2021 Yes Yes antagonist
CR-845 difelikefalin Cara Therapeutics opioid receptor agonist Pruritus IV/PO InTrial 2H2021 No No
pIL-12 tavokinogene telsaplasmid OncoSec Medical gene therapy Melanoma Intratumoral InTrial 2H2021 Yes Yes
MD-1003 MD-1003 MedDay biotin Multiple sclerosis PO InTrial 2H2021 Yes No
Duchenne muscular VBP-15 vamorolone Santhera corticosteroid PO InTrial 2H2021 Yes Yes dystrophy
ZYN-002 ZYN-002 Zynerba cannabinoid product Fragile X syndrome TOP InTrial 2H2021 Yes Yes
Calliditas/ Kyowa Hakko PL-56 budesonide corticosteroid Nephropathy PO InTrial 2H2021 No No Kirin
fibroblast growth factor dovitinib dovitinib Oncology Venture receptor 3 (FGFR3) Renal cell carcinoma PO InTrial 2H2021 Yes No inhibitor
CastiaRx.com // p: 866.516.2121 21 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
alpha-2/beta-1 adrenergic vascular Ehlers-Danlos Edsivo celiprolol HCl Acer Therapeutics PO CRL 2021 Yes Yes agent Syndrome
Tlando testosterone Lipocine androgen Hypogonadism PO CRL 2021 No No
PRO-145223 etrolizumab Genentech IgG1 monoclonal antibody Ulcerative colitis SC InTrial 2021 Yes No
chemokine (CXCR4) POL-6326 balixafortide Polyphor Transplant/ Breast cancer IV InTrial 2021 Yes No antagonist
Duchenne muscular idebenone idebenone Santhera co-enzyme Q-10 analog PO InTrial 2021 Yes Yes dystrophy
Chronic myelogenous ABL-001 asciminib Novartis allosteric Bcr-Abl inhibitor PO InTrial 2021 Yes Yes leukemia
PPP-002 PPP-002 Tetra Bio-Pharma botanical drug Pain Undisclosed InTrial 2021 No No
sodium-dependent glucose transporter 1 (SGLT-1) and Zynquista sotagliflozin Sanofi/ Lexicon Diabetes mellitus PO CRL 2021 No No SGLT-2 inhibitor
JNJ-3872 (VX- 787) pimodivir Johnson & Johnson/ Vertex viral protein inhibitor Influenza PO InTrial 2021 No No
V1A vasopressin receptor RG-7314 (RO- 5285119) balovaptan Roche Autism spectrum disorder PO InTrial 2021 Yes No antagonist
HER2/neu receptor RG-6264 trastuzumab/ pertuzumab Roche Breast cancer SC InTrial 2021 Yes No antagonist
toll-like receptor 9 (TLR- IMO-2125 tilsotolimod Idera Melanoma SC/ intratumoral InTrial 2021 Yes Yes 9) agonist
CastiaRx.com // p: 866.516.2121 22 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
ARYx Therapeutics/ vitamin K epoxide ATI-5923 tecarfarin Anticoagulation PO InTrial 2021 No No Armetheon reductase enzyme inhibitor
Acute myelogenous RG-7388 (RO- 5503781) idasanutlin Roche MDM2 antagonist PO InTrial 2021 Yes No leukemia
brincidofovir DNA-directed DNA Adenovirus/ CMX-001 Chimerix PO InTrial 2021 No Yes hexadecyloxyprop yl ester polymerase inhibitor Cytomegalovirus/ Smallpox
neurokinin 1 receptor (NK- LY-686017 tradipitant Vanda Pharmaceuticals Motion sickness PO InTrial 2021 No No 1R) antagonist
Prostate cancer; breast RG-7440 ipatasertib Roche pan-Akt inhibitor PO InTrial 2021 Yes No cancer
c-Met receptor tyrosine EMD-1214063 tepotinib Merck Non-small cell lung cancer PO InTrial 2021 Yes No kinase inhibitor
RTA-408 omaveloxolone Reata Pharmaceuticals Nrf2 activator Friedreich's ataxia PO InTrial 2021 Yes Yes
vascular endothelial Recentin cediranib AstraZeneca growth factor receptor Ovarian cancer PO InTrial 2021 Yes Yes (VEGF) antagonists
Growth hormone MOD-401 somatrogon OPKO Health/ Pfizer enzyme replacement SC InTrial 2021 Yes Yes deficiency
DS-100 DS-100 Eton undisclosed Ophthalmological disease SC InTrial 2021 No No
S5G4T-1 (DER- 45-EV) benzoyl peroxide Sol-Gel Technologies benzoyl peroxide Rosacea TOP InTrial 2021 No No
ADA-transduced Adenosine deaminase- OTL-101 autologous stem cell Orchard Therapeutics gene therapy deficient severe combined Undisclosed InTrial 2021 Yes Yes therapy immunodeficiency
CastiaRx.com // p: 866.516.2121 23 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Duchenne muscular CAT-1004 edasalonexent Catabasis NF-kB inhibitor PO InTrial Late 2021 Yes Yes dystrophy
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
angiopoietin-like 3 REGN-1500 evinacumab Regeneron Hyperlipidemia IV/SC InTrial Late 2021 Yes No (ANGPTL3) antagonist
etranacogene AMT-061 uniQure gene therapy Hemophilia B IV InTrial Late 2021 Yes No dezaparvovec
Anti-VEGF (vascular Wet age-related macular PDS-1.0 ranibizumab Roche/ Genentech Intravitreal implant InTrial Late 2021 Yes No endothelial growth factor) degeneration
End-stage renal disease/ Humacyl human acellular vessel Humacyte cellular therapy Implant InTrial Late 2021 Yes No Peripheral artery disease
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
MK-0594 (VPD- 737) serlopitant Menlo NK-1 receptor antagonist Pruritus PO InTrial Late 2021 Yes No
chemoattractant receptor- QAW-039 (NVP-QAW- 039) fevipiprant Novartis homologous molecule Asthma PO InTrial Late 2021 Yes No (CRTH2) antagonist
CastiaRx.com // p: 866.516.2121 24 Brand Pipeline Forecast 4th Quarter 2019
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
tripotassium citrate Distal rental tubular ADV-7103 monohydrate/ potassium Advicenne Undisclosed PO InTrial Late 2021 Yes No acidosis hydrogen carbonate
PW-4142 (T- 111) nalbuphine ER Trevi Therapeutics/ Endo opioid agonist/ antagonist Prurigo nodularis PO InTrial Late 2021 No No
GSK-2696274 (OTL-200) GSK-2696274 (OTL-200) GlaxoSmithKline gene therapy Leukodystrophy IV InTrial Late 2021 Yes Yes
paroxysmal nocturnal Ultomiris SC ravulizumab-cwvz Alexion C5 complement inhibitor hemoglobinuria; Hemolytic SC InTrial Late 2021 Yes Yes uremic syndrome
janus kinase 1 (JAK-1) PF-04965842 abrocitinib Pfizer Atopic dermatitis PO InTrial Late 2021 Yes No inhibitor
COR-003 levoketoconazole Strongbridge azole antifungal Cushing's syndrome PO InTrial Late 2021 No Yes
hypoxia-inducible factor- AKB-6548 vadadustat Akebia Therapeutics prolyl hydroxylase (HIF- Anemia PO InTrial Late 2021 Yes No PH) inhibitor
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 25