Brand Pipeline Forecast 1st Quarter 2020
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
calcitonin gene-related BMS-927711 (BHV-3000) rimegepant sulfate Biohaven peptide (CGRP) receptor Migraine PO Filed NDA 2/2020 No No antagonist
ATP citrate lyase ETC-1002/ bempedoic acid/ Esperion Therapeutics inhibitor/cholesterol Hypercholesterolemia PO Filed NDA 2/26/2020 No No ezetimibe ezetimibe absorption inhibitor
dopamine receptor APD-421 amisulpride Acacia Nausea/ vomiting IV Filed NDA 2/26/2020 No No antagonist
gonadotropin-releasing FP-001 (LMIS) leuprolide mesylate Foresee Prostate cancer SC Filed NDA 2/2020 Yes No hormone (GnRH) analog
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) naloxone nasal spray naloxone Insys Therapeutics opioid antagonist Opioid dependence Intranasal Filed NDA 3/15/2020 No No
ET-105 lamotrigine Eton anticonvulsant Epilepsy PO Filed NDA 3/17/2020 No No
sphingosine 1-phosphate ozanimod ozanimod Celgene 1 (S1PR1) and 5 (S1PR5) Multiple sclerosis PO Filed NDA 3/25/2020 Yes No receptor modulator
serotonin receptor Fintepla fenfluramine Zogenix Dravet syndrome PO Filed NDA 3/25/2020 Yes Yes agonist
Rizaport rizatriptan IntelGenx triptan Acute migraines PO Filed NDA 3/26/2020 No No
CastiaRx.com // p: 866.516.2121 1 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
anesthetic/ Nonsteroidal HTX-011 bupivacaine/ meloxicam Heron Therapeutics Anti-inflammatory Drug Pain Instillation Filed NDA 3/26/2020 No No (NSAID)
paclitaxel injection Sun Pharma Advanced Breast Cancer; Lung SPARC-1028, SPARC- concentrate for Research Company taxane Cancer; Pancreatic IV Filed NDA 1Q2020 No No 1210, SPARC-1023 suspension (SPARC) Cancer
Aximris XR oxycodone ER IntelliPharmaCeutics opioid agonist Pain PO Filed NDA 1Q2020 No No
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
non-steroid anti- 3/2020 - E-58425 celecoxib/ tramadol Esteve inflammatory Acute pain PO Filed NDA No No 4/2020 drug/opioid 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
MitoGel mitomycin C UroGen alkylating agent Urothelial cancer Intravesical Filed NDA 4/18/2020 No Yes
meningococcal polysaccharide Meningococcal Men Quad TT (serogroups A, C, Y, and Sanofi antibacterial IM Filed BLA 4/25/2020 No No meningitis W135) tetanus toxoid conjugate vaccine
CastiaRx.com // p: 866.516.2121 2 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
catechol-O- Ongentys opicapone Neurocrine Biosciences methyltransferase Parkinson's disease PO Filed NDA 4/26/2020 No No (COMT) inhibitor
Pulmonary arterial Trevyent treprostinil United Therapeutics prostacyclin analog SC Filed NDA 4/27/2020 Yes Yes hypertension isatuximab isatuximab Sanofi CD38 antagonist Multiple myeloma IV Filed BLA 4/30/2020 Yes Yes
selective MEK kinase 4/2020 to selumetinib selumetinib AstraZeneca/ Merck Neurofibromatosis PO Filed NDA Yes Yes inhibitor 5/2020
SEP-225289 dasotraline Sunovion triple reuptake inhibitor Binge eating disorder PO Filed NDA 5/14/2020 No No
non-ergoline dopamine APL-130277 apomorphine Sunovion Parkinson's disease PO Filed NDA 5/21/2020 No No agonist
Roche/ PTC RG-7916 (RO- 7034067) risdiplam SMN2 splicing modifier Spinal muscular atrophy PO Filed NDA 5/24/2020 Yes Yes Therapeutics
Amphora Amphora Evofem Biosciences spermicidal agent Pregnancy prevention VG Filed NDA 5/25/2020 No No
selective FGFR1/2/3 INCB-54828 pemigatinib Incyte Biliary tract cancer PO Filed NDA 5/30/2020 Yes Yes inhibitor nadofaragene nadofaragene 5/2020 - Ferring Pharmaceuticals gene therapy Bladder cancer Intravesical Filed BLA Yes No firadenovec firadenovec 6/2020
FMX-103 minocycline Foamix tetracyclines Rosacea TOP Filed NDA 6/2/2020 No No
RS7-SN-38 antibody- IMMU-132 sacituzumab govitecan Immunomedics Breast cancer IV Filed BLA 6/2/2020 Yes No drug conjugate
morpholino antisense Duchenne muscular NS-065 viltolarsen Nippon Shinyaku IV Filed BLA 6/2/2020 Yes Yes oligonucleotide dystrophy
CastiaRx.com // p: 866.516.2121 3 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
EM-100 ketotifen Eton antihistamine Allergic conjunctivitis OP Filed NDA 6/11/2020 No No
Contepo fosfomycin Nabriva Therapeutics cell wall inhibitor Bacterial infections IV Filed NDA 6/19/2020 Yes No
EVK-001 metoclopramide Evoke Pharma antidopiminergics Diabetic gastroparesis Intranasal Filed NDA 6/19/2020 No No
Intercept farnesoid X receptor Nonalcoholic obeticholic acid obeticholic acid PO Filed NDA 6/26/2020 Yes No Pharmaceuticals (FXR) agonist steatohepatitis
Mycapssa (Octreolin) octreotide Chiasma somatostatin analog Acromegaly PO Filed NDA 6/2020 Yes Yes
CD20 monoclonal OMB-157 ofatumumab Novartis Multiple sclerosis SC Filed BLA 6/2020 Yes No antibody
osmotic gradient Bronchitol mannitol Pharmaxis enhancer; mucus Cystic fibrosis INH Filed NDA 2Q2020 No Yes clearance enhancer insulin glargine insulin glargine Mylan/ Biocon Long-acting insulin Diabetes mellitus SC CRL Mid-2020 No No
Age-related macular 6/2020 – abicipar pegol abicipar pegol Allergan VEGF-A inhibitor Intravitreal Filed BLA Yes No degeneration 7/2020
Neuromyelitis optica 6/2020 – MEDI-551 inebilizumab Viela Bio CD-19 antagonist IV Filed BLA Yes Yes spectrum disorder 7/2020 nonsteroidal anti- 6/2020 – DFN-15 celecoxib Dr. Reddy inflammatory drug Migraine PO Filed NDA No No 7/2020 (NSAID) collagenase clostridium collagenase clostridium Endo protease enzyme Cellulite SC Filed BLA 7/6/2020 Yes No histolyticum histolyticum
CastiaRx.com // p: 866.516.2121 4 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
daratumumab (with humanized anti-CD38 Darzalex recombinant human Janssen Multiple myeloma SC Filed BLA 7/12/2020 Yes Yes monoclonal antibody hyaluronidase)
VP-102 VP-102 Verrica antiviral Molluscum TOP Filed NDA 7/13/2020 No No
Osmotica/ Vertical alpha-adrenergic Acquired blepharoptosis RVL-1201 oxymetazoline OP Filed NDA 7/16/2020 No No Pharmaceuticals receptor agonist (droopy eyelid)
calcipotriene/ vitamin D analog/ MC2-01 MC2 Therapeutics Psoriasis TOP Filed NDA 7/20/2020 No No betamethasone corticosteroid
sodium oxybate dopamine receptor JZP-258 Jazz Narcolepsy PO Filed NDA 7/21/2020 Yes Yes extended-release agonist
acetylcholinesterase Corplex donepezil donepezil Corium International Alzheimer's disease TOP Filed NDA 7/30/2020 No No inhibitor
Glucose transport type 1 UX-007 triheptanoin Ultragenyx medium chain fatty acid PO Filed NDA 7/31/2020 Yes Yes deficiency syndrome
Non-small cell lung 7/2020 - LOXO-292 selpercatinib Eli Lilly/ Loxo Oncology RET inhibitor PO Filed NDA Yes No cancer; thyroid cancer 8/2020
nucleoside metabolic Myelodysplastic 7/2020 - ASTX-727 decitabine and E- 7727 Astex Pharmaceuticals PO Filed NDA Yes Yes inhibitor syndrome 8/2020
Viaskin Peanut Viaskin Peanut DBV Technologies Immunotherapy Peanut allergy TOP Filed BLA 8/5/2020 No No
BMS-663068 fostemsavir Bristol-Myers Squibb HIV attachment inhibitor HIV PO Filed NDA 8/5/2020 Yes No
CastiaRx.com // p: 866.516.2121 5 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
chimeric antigen KTE-X19 KTE-X19 Gilead receptor (CAR) T cell Mantle cell lymphoma IV Filed BLA 8/10/2020 Yes Yes therapy
TRV-130 oliceridine Trevena opioid receptor agonist Pain IV Filed NDA 8/10/2020 Yes No
BCX-7353 berotralstat BioCryst kallikrein inhibitor Hereditary angioedema PO Filed NDA 8/11/2020 Yes Yes
Non-small cell lung INCB-028060 (INC-280) capmatinib Novartis/ Incyte cMET inhibitor PO Filed NDA 8/11/2020 Yes Yes cancer
Pedmark (STS) sodium thiosulfate Fennec reducing agent Hearing loss IV Filed NDA 8/11/2020 Yes Yes
PDGFR-alpha kinase Gastrointestinal stromal DCC-2618 ripretinib Deciphera PO Filed NDA 8/14/2020 Yes Yes inhibitor tumors
GlaxoSmithKline/ Seattle anti-BCMA antibody- GSK-2857916 belantamab mafodotin Multiple myeloma SC Filed BLA 8/16/2020 Yes Yes Genetics drug conjugate
Zepsyre lurbinectidin PharmaMar alkylating agent Small cell lung cancer IV Filed NDA 8/16/2020 Yes Yes
janus associated kinase- GLPG-0634 filgotinib Gilead Rheumatoid arthritis PO Filed NDA 8/18/2020 Yes No 1 (JAK) inhibitor
chimeric antigen lisocabtagene Bristol-Myers Squibb/ Diffuse large B-cell JCAR-017 receptor (CAR) T cell IV Filed BLA 8/18/2020 Yes Yes maraleucel Celgene lymphoma therapy
HER2 oncoprotein MAGH-22 margetuximab MacroGenics Breast cancer IV Filed BLA 8/19/2020 Yes No antagonist
CastiaRx.com // p: 866.516.2121 6 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
carrier protein TRC-101 veverimer Tricida Chronic kidney disease PO Filed NDA 8/22/2020 Yes No modulator
ErbB-2 (Her-2/neu) ARRY-380 (ONT-380) tucatinib Seattle Genetics Breast cancer PO Filed NDA 8/23/2020 Yes Yes inhibitor
valoctocogene BMN-270 BioMarin gene therapy Hemophilia A IV Filed BLA 8/23/2020 Yes Yes roxaparvovec
Winlevi clascoterone Cassiopea androgen antagonist Acne vulgaris TOP Filed NDA 8/27/2020 No No
Diffuse large B-cell MOR-208 tafasitamab MorphoSys/ Xencor CD-19 antagonist IV Filed BLA 8/28/2020 Yes Yes lymphoma
interleukin-6 (IL-6) 8/2020 - SA-237 satralizumab Roche Neuromyelitis optica SC Filed BLA Yes Yes monoclonal antibody 9/2020
recombinant human Growth hormone NNC-0195- 0092 somapacitan Novo Nordisk SC Filed BLA 9/21/2020 Yes No growth hormone (rhGH) deficiency
LJPC-0118 artesunate La Jolla Pharmaceutical protozoacide Malaria Undisclosed Filed NDA 9/25/2020 No Yes
Libervant diazepam Aquestive Therapeutics benzodiazepine Seizures PO Filed NDA 9/27/2020 No Yes
Prochymal remestemcel-L Mesoblast mesenchymal stem cells Graft vs. Host disease IV Filed BLA 9/30/2020 Yes Yes
LY-900014 insulin lispro Eli Lilly insulins Diabetes mellitus SC Filed BLA 3Q2020 No No
Infacort hydrocortisone Diurnal Group corticosteroid Adrenal insufficiency PO Filed NDA 10/2/2020 No Yes
CastiaRx.com // p: 866.516.2121 7 Brand Pipeline Forecast 1st Quarter 2020
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 Filed NDA 10/9/2020 No No
Qtrypta zolmitriptan Zosano triptan Acute migraines TOP Filed NDA 10/20/2020 No No
granulocyte colony- SPI-2012 eflapegrastim Spectrum/ Hanmi Neutropenia SC Filed BLA 10/24/2020 Yes No stimulating factor (GCSF)
selective norepinephrine Attention deficit SPN-812 viloxazine Supernus PO Filed NDA 11/8/2020 No No reuptake inhibitor hyperactivity disorder
dopamine receptor olanzapine/ Schizophrenia/ Bipolar ALKS-3831 Alkermes antagonist/ opioid PO Filed NDA 11/15/2020 No No samidorphan disorder receptor antagonist
Glabellar lines (frown RT-002 (Daxi) daxibotulinumtoxi nA Revance Therapeutics botulinum toxins IM Filed BLA 11/25/2020 Yes No lines)
Pulmonary arterial LIQ-861 treprostinil Liquidia Technologies prostacyclin analog INH Filed NDA 11/27/2020 Yes No hypertension
anti-parasitic, anti- nifurtimox nifurtimox Bayer Chagas disease PO Filed NDA 11/30/2020 No Yes protozoal
trastuzumab/ HER2/neu receptor 11/2020 - RG-6264 Roche Breast cancer SC Filed BLA Yes No pertuzumab antagonist 12/2020
hypoxia-inducible factor FG-4592 roxadustat FibroGen/ AstraZeneca prolyl hydroxylase (HIF- Anemia PO Filed NDA 12/23/2020 Yes No PHI)
CastiaRx.com // p: 866.516.2121 8 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
serotonin- norepinephrine- Major depressive LY-03005 ansofaxine Luye Pharma PO Filed NDA 12/26/2020 No No dopamine triple disorder reuptake inhibitor
selective beta 3 MK-4618 (KRP- 114V, vibegron Urovant Sciences adrenergic receptor Overactive bladder PO Filed NDA 12/29/2020 No No RVT-901) agonist
siRNA targeting The Medicines proprotein convertase inclisiran inclisiran Hyperlipidemia SC Filed NDA 12/2020 Yes Yes Company/ Novartis subtilisin kexin type 9 (PCSK9)
nerve growth factor tanezumab tanezumab Pfizer/ Eli Lilly Osteoarthritis SC Filed BLA 12/2020 Yes No antibody
phosphoinositide-3 Marginal zone TGR-1202 umbralisib TG Therapeutics kinase (PI3K) delta lymphoma/ follicular PO InTrial 4Q2020 Yes Yes inhibitor lymphoma
REGN-EB3 REGN-EB3 Regeneron anti-Ebola virus Ebola IV InTrial 4Q2020 Yes Yes
C-C chemokine receptor PRO-140 leronlimab CytoDyn HIV SC InTrial 4Q2020 Yes Yes 5 (CCR5) antagonist
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
CastiaRx.com // p: 866.516.2121 9 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
lentiviral beta- globin Zynteglo (LentiGlobin) Bluebird Bio gene therapy Beta-thalassemia IV InTrial 4Q2020 Yes Yes gene transfer
131I-8H9 omburtamab Y-mAbs Therapeutics B7-H3 antagonist Brain cancer Undisclosed InTrial 4Q2020 Yes Yes
3-F8 (Hu-3F8) naxitamab Y-mAbs Therapeutics GD2 antagonist Neuroblastoma IV InTrial 4Q2020 Yes Yes
Non-small cell lung BLU-667 pralsetinib Blueprint Medicines RET inhibitor PO InTrial 4Q2020 Yes Yes cancer
mometasone furoate/ corticosteroid/ GSP-301 Glenmark Allergic rhinitis Intranasal CRL 2H2020 No No olopatadine HCl antihistamine
chimeric antigen bb-2121 idecabtagene vicluecel Celgene/ Bluebird Bio receptor (CAR) T cell Multiple myeloma IV InTrial 2H2020 Yes Yes therapy
Hutchinson-Gilford Eiger Progeria Syndrome EBP-994 (rEBP- 994) lonafarnib prenylation inhibitor PO InTrial 2H2020 Yes Yes Biopharmaceuticals (HGPS or progeria) and progeroid laminopathies
HIV integrase inhibitor/ cabotegravir (long- non-nucleoside reverse TMC-278-LA acting)/ rilpivirine (long- ViiV Healthcare HIV IM CRL 2020 Yes No transcriptase inhibitor acting) (NNRTI)
S-265744 (S/GSK- cabotegravir ViiV Healthcare HIV integrase inhibitor HIV PO CRL 2020 Yes No 1265744)
CastiaRx.com // p: 866.516.2121 10 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
glycolate oxidase ALNG-01 lumasiran Alnylam Hyperoxaluria Intranasal InTrial Late 2020 Yes Yes antagonist
RVT-802 RVT-802 Enzyvant/Roivant Tissue-based therapy Congenital athymia Implant CRL Late 2020 Yes Yes
alpha galactosidase PRX-102 Protalix enzyme replacement Fabry disease IV InTrial Late 2020 Yes No (pegunigalsidase alfa)
corticosteroid/ long- acting muscarinic budesonide/ receptor antagonist Chronic obstructive BGF-MDI (PT- 010) glycopyrronium/ AstraZeneca INH CRL Late 2020 No No (LAMA)/ long-acting pulmonary disease formoterol beta 2 adrenergic receptor agonist (LABA)
CD-20 monoclonal antibody/ Chronic lymphocytic TG-1303 ublituximab/ TGR- 1202 TG Therapeutics phosphoinositide-3 leukemia/ Non- Hodgkin IV/PO InTrial Late 2020 Yes Yes kinase (PI3K) delta lymphoma inhibitor
Rhythm/ Camurus/ melanocortin 4 receptor Rare genetic disorders of BIM-22493 (RM-493) setmelanotide SC InTrial Late 2020 Yes Yes Ipsen (MC4R) agonist obesity
CLS-1001 triamcinolone acetonide Clearside corticosteroid Macular edema Intraocular CRL Late 2020 Yes No
CastiaRx.com // p: 866.516.2121 11 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Tentative Bafiertam monomethyl fumarate Banner Life Sciences Nrf2 pathway activator Multiple sclerosis PO Late 2020 Yes No Approval
Hematopoietic stem cell anti-MASP-2 monoclonal transplant- associated OMS-721 narsoplimab Omeros IV/SC InTrial Late 2020 Yes Yes antibody thrombotic microangiopathy
Orphan Therapeutics/ Lucassin terlipressin V-1 (vasopressin) agonist Hepato-renal syndrome IV CRL Late 2020 Yes Yes Ikaria
BridgeBio Pharma/ molybdenum cofactor Molybdenum cofactor ALXN-1101 fosdenopterin IV InTrial Late 2020 Yes Yes Origin Biosciences stimulant deficiency
opioid receptor agonist Opioid use disorder/ Tentative CAM-2038 buprenorphine Camurus/ Braeburn SC Late 2020 Yes No (partial) Pain Approval
Zimhi naloxone Adamis opioid antagonist Opioid dependence IM CRL Late 2020 No No
integrin receptor Ulcerative colitis/ Entyvio (SC formulation) vedolizumab Takeda SC CRL Late 2020 Yes No antagonist Crohn's disease
PharmaEssentia/ AOP ropeginterfero n alfa-2b ropeginterferon alfa-2b interferon Polycythemia vera SC InTrial Late 2020 Yes Yes Orphan
Neutrolin (CRMD-003, citrate/ taurolidine/ antimicrobial agent/ Catheter-related CorMedix IV InTrial Late 2020 No No CRMD-004) heparin anticoagulant infections
morpholino antisense Duchenne muscular SRP-4045 casimersen Sarepta IV InTrial Late 2020 Yes Yes oligonucleotide dystrophy
Apealea (Paclical) paclitaxel Oasmia taxane Ovarian cancer IV InTrial Late 2020 Yes Yes
CastiaRx.com // p: 866.516.2121 12 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Ryplazim human plasminogen ProMetic/ Hematech plasminogen Plasminogen deficiency IV CRL Late 2020 Yes Yes
2021 Possible Launch Date
PD-1 checkpoint TSR-042 dostarlimab GlaxoSmithKline Endometrial cancer IV Filed BLA 1/14/2021 Yes No inhibitor
gene transcription Duchenne muscular Translarna ataluren PTC Therapeutics PO CRL 1Q2021 Yes Yes modulator dystrophy
StrataGraft Skin Tissue StrataGraft Skin Tissue Mallinckrodt autologous skin tissue Burn injury TOP InTrial 1Q2021 Yes Yes
KPI-121 0.25% loteprednol etabonate Kala corticosteroid Dry eyes OP CRL 1Q2021 No No
ET-103 levothyroxine Eton Pharmaceuticals L-thyroxine Hypothyroidism PO InTrial 1Q2021 No No
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
HM-30181A/ P-glycoprotein pump Oraxol Athenex Breast cancer PO InTrial 1Q2021 Yes No paclitaxel inhibitor/ taxane
Aromatic L-amino acid AGIL-AADC AGIL-AADC Agilis Biotherapeutics gene therapy Intracerebral InTrial 1Q2021 Yes Yes decarboxylase deficiency
amyloid beta-protein BIIB-037 aducanumab Biogen Alzheimer's disease IV InTrial 1Q2021 Yes No inhibitor
Furoscix furosemide scPharmaceuticals diuretic Heart failure SC CRL 1Q2021 Yes No
CastiaRx.com // p: 866.516.2121 13 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
DNA methylation CC-486 azacitidine Celgene Acute myeloid leukemia PO InTrial 1Q2021 Yes Yes inhibitor
D-threo- Attention deficit KP-415 methylphenidate KemPharm CNS stimulant PO InTrial 1Q2021 No No hyperactivity disorder controlled-release
Myovant Sciences/ gonadotropin-releasing Uterine fibroids/ TAK-385 relugolix Roivant Sciences/ hormone (GnRH) PO InTrial 1H2021 Yes No Endometriosis Takeda receptor antagonist
sphingosine 1 phosphate RG-3477 (ACT- 128800) ponesimod Johnson & Johnson Multiple sclerosis PO InTrial 1H2021 Yes No (S1P) receptor agonist
TransCon Growth growth hormone Short stature/ Growth ACP-001 Ascendis SC InTrial 1H2021 Yes No Hormone prodrug hormone deficiency
C5a receptor (C5aR) CCX-168 avacopan ChemoCentryx/ Galencia Vasculitis PO InTrial 1H2021 Yes Yes antagonist arimoclomol arimoclomol Orphazyme cytoprotectives Niemann-Pick Disease PO InTrial 1H2021 Yes Yes
NX-1207 (NYM-4805, Benign prostatic fexapotide triflutate Nymox pro-apoptotic Intratumoral InTrial 1H2021 Yes No REC 0482) hyperplasia sulopenem sulopenem Iterum Therapeutics carbapenem Bacterial infection IV/PO InTrial 1H2021 No No
anti-ECAM exotoxin A Vicinium (VB-4- 845) oportuzumab monatox Sesen Bio Bladder cancer Intravesical InTrial 1H2021 Yes No fusion protein
glucan synthase SCY-078 (MK- 3118) ibrexafungerp Scynexis Fungal infections IV/PO InTrial 1H2021 No Yes inhibitors
CastiaRx.com // p: 866.516.2121 14 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
Luveniq voclosporin Aurinia Pharmaceuticals calcineurin inhibitor Lupus nephritis PO InTrial 1H2021 Yes No
C-type natriuretic BMN-111 vosoritide (vasoritide) BioMarin/ Chugai Achondroplasia SC InTrial 1H2021 Yes Yes peptide (CNP) analog
X-linked myotubular AT-132 (AAV8- MTM1) AT-132 (AAV8- MTM1) Audentes Therapeutics gene therapy IV InTrial Mid-2021 Yes Yes myopathy
complement C1s BIVV-009 sutimlimab Sanofi Cold agglutinin disease IV InTrial Mid-2021 Yes Yes subcomponent inhibitor
ZYN-002 ZYN-002 Zynerba cannabinoid product Fragile X syndrome TOP InTrial Mid-2021 Yes Yes
non-steroidal anti- AXS-07 meloxicam/rizatri ptan Axsome Therapeutics inflammatory Migraine PO InTrial Mid-2021 No No drug/triptan
Acute myeloid iodine I 131 monoclonal anti-CD45 monoclonal leukemia/ Iomab-B Actinium IV InTrial Mid-2021 Yes Yes antibody BC8 antibody Myelodysplastic syndrome
vascular endothelial Recentin cediranib AstraZeneca growth factor receptor Ovarian cancer PO InTrial Mid-2021 Yes Yes (VEGF) antagonist
phosphodiesterase type Benign prostatic TadFin tadalafil and finasteride Veru 5 inhibitor /5-alpha- PO InTrial Mid-2021 No No hyperplasia reductase inhibitor
CastiaRx.com // p: 866.516.2121 15 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
CUTX-101 copper histidinate Fortress Biotech copper histidinate Menkes Disease SC InTrial Mid-2021 Yes Yes
non-ATP competitive Myelodysplastic Estybon rigosertib Onconova IV InTrial Mid-2021 Yes Yes kinase inhibitor syndrome
Diffuse large B-cell ADCT-402 loncastuximab tesirine ADC Therapeutics antibody drug conjugate IV InTrial Mid-2021 Yes Yes lymphoma
respiratory syncytial Respiratory syncytial RSV-F (ResVax) Novavax vaccine IM InTrial Mid-2021 Yes No virus vaccine virus infection
interleukin-17 (IL-17) UCB-4940 bimekizumab UCB Plaque psoriasis IV InTrial Mid-2021 Yes No receptor inhibitor
histone deacetylase entinostat entinostat Syndax Breast cancer PO InTrial Mid-2021 Yes No (HDAC) inhibitor
c-Met receptor tyrosine Non-small cell lung EMD-1214063 tepotinib Merck PO InTrial Mid-2021 Yes No kinase inhibitor cancer
Lymphoproliferative EBV-CTL tabelecleucel Atara Biotherapeutics cell therapy IV InTrial Mid-2021 Yes Yes disorder
tavokinogene pIL-12 OncoSec Medical gene therapy Melanoma Intratumoral InTrial Mid-2021 Yes Yes telsaplasmid
GZ-402666 (NeoGAA) avalglucosidase alfa Sanofi enzyme therapy Pompe disease IV InTrial Mid-2021 Yes No
CastiaRx.com // p: 866.516.2121 16 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
PD-1 checkpoint PDR-001 spartalizumab Novartis Melanoma IV InTrial Mid-2021 Yes No inhibitor
recombinant human AT-GAA acid alpha- glucosidase + Amicus enzyme therapy Pompe disease IV InTrial Mid-2021 Yes Yes AT2220
BGJ-398 infigratinib BridgeBio FGFR inhibitor Biliary tract cancer PO InTrial Mid-2021 Yes Yes
Acute myelogenous RG-7388 (RO- 5503781) idasanutlin Roche MDM2 antagonist PO InTrial Mid-2021 Yes No leukemia
elivaldogene cerebral adreno- Lenti-D Bluebird Bio gene therapy IV InTrial Mid-2021 Yes Yes tavalentivec myeloneuropathy
ROCK2 (Rho-associated KD-025 KD-025 Kadmon coiled-coiled kinase 2) Graft vs. Host disease PO InTrial Mid-2021 No Yes inhibitor
janus kinase 1 (JAK-1) PF-04965842 abrocitinib Pfizer Atopic dermatitis PO InTrial 3Q2021 Yes No inhibitor
C-C chemokine receptor Nonalcoholic TBR-652 (TAK- 652, CVC) cenicriviroc Allergan 5 (CCR5) and receptor 2 PO InTrial 4Q2021 Yes No steatohepatitis antagonist
Duchenne muscular VBP-15 vamorolone Santhera corticosteroid PO InTrial 4Q2021 Yes Yes dystrophy
CastiaRx.com // p: 866.516.2121 17 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
nicotinic acetylcholine OS-01 nasal spray OC-01 Oyster Point Pharma receptor (nAChR) Dry eye disease Intranasal InTrial 4Q2021 No No agonist
opioid receptor OPNT-003 nalmefene Opiant Opioid overdose Intranasal InTrial 4Q2021 No No antagonist
Growth hormone MOD-401 somatrogon OPKO Health/ Pfizer enzyme replacement SC InTrial 2H2021 Yes Yes deficiency
MacroGenics/ PRV-031 teplizumab CD3 antigen inhibitor Diabetes mellitus IV InTrial 4Q2021 Yes Yes Provention Bio
NK-1 receptor MK-0594 (VPD- 737) serlopitant Menlo Pruritus PO InTrial 2H2021 Yes No antagonist
selective alpha 2a Schizophrenia and BXCL-501 dexmedetomidine BioXcel Therapeutics PO InTrial 2H2021 No No receptor agonist bipolar disorder
IDP-124 pimecrolimus Bausch Health calcineurin Inhibitor Atopic dermatitis TOP InTrial 2H2021 No No
MD-1003 MD-1003 MedDay biotin Multiple sclerosis PO InTrial 2H2021 Yes No
interleukin-13 (IL-13) CAT-354 tralokinumab Leo Pharma Atopic dermatitis SC InTrial 2H2021 Yes No inhibitor
tumor vascular NPI-2358 plinabulin BeyondSpring Neutropenia IV InTrial 2H2021 Yes No disrupting agent (tVDA)
CastiaRx.com // p: 866.516.2121 18 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
interferon receptor Systemic lupus MEDI-546 anifrolumab AstraZeneca/ BMS IV InTrial 2H2021 Yes No antagonist erythematosus
chimeric antigen LCAR-B38M LCAR-B38M Johnson & Johnson receptor (CAR) T cell Multiple myeloma Undisclosed InTrial 2H2021 Yes Yes therapy
ARGX-113 efgartigimod Argen NV Fc antagonist Myasthenia gravis IV/SC InTrial 2H2021 Yes Yes
Calliditas/ Kyowa Hakko PL-56 budesonide corticosteroid Nephropathy PO InTrial 2H2021 No Yes Kirin
Attention deficit SPN-810 molindone Supernus atypical antipsychotic PO InTrial 2H2021 No No hyperactivity disorder
CR-845 difelikefalin Cara Therapeutics opioid receptor agonist Pruritus IV/PO InTrial 2H2021 No No
GSK-2696274 (OTL-200) GSK-2696274 (OTL-200) GlaxoSmithKline gene therapy Leukodystrophy IV InTrial 2H2021 Yes Yes
tumor infiltrating LN-145 lifileucel Iovance Biotherapeutics Cervical Cancer IV InTrial 2H2021 Yes No lymphocyte
selective peroxisome proliferator-activated Nonalcoholic GFT-505 elafibranor Genfit PO InTrial 2H2021 Yes No receptor (PPAR) steatohepatitis modulator
Sci-B-Vac hepatitis B vaccine VBI Vaccines vaccine Hepatitis B IM InTrial 2H2021 No No
CastiaRx.com // p: 866.516.2121 19 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
N-methyl-D-aspartate Dextro- methorphan/ Treatment-resistant AXS-05 Axsome (NMDA) antagonist/ PO InTrial 2H2021 No No bupropion depression antidepressant
Dihydro- ergotamine INP-104 Impel/ 3M ergot derivative Acute migraines Intranasal InTrial 2H2021 No No mesylate
TWIN (S6G5T- 1; S6G5T- benzoyl peroxide/ Sol-Gel Technologies retinoid Acne vulgaris TOP InTrial 2H2021 No No 3) tretinoin
177Lu-PSMA- Lutetium Novartis Radiopharmaceutical Prostate cancer IV InTrial 2H2021 Yes No 617
fibroblast growth factor dovitinib dovitinib Oncology Venture receptor 3 (FGFR3) Renal cell carcinoma PO InTrial 2H2021 Yes No inhibitor
aldose reductase AT-007 AT-007 Applied Therapeutics Galactosemia Undisclosed InTrial 2H2021 Yes Yes inhibitor
Nedd 8 Activating Myelodysplastic MLN-4924 (TAK-92) pevonedistat Takeda Enzyme (NAE) IV InTrial 2021 Yes No syndrome antagonist
Prostate cancer; breast RG-7440 (GDC- 0068) ipatasertib Roche pan-Akt inhibitor PO InTrial 2021 Yes No cancer
Oralair Mites dust mite peptide Stallergenes/ Shionogi vaccine Dust mite allergic rhinitis PO InTrial 2021 Yes No
RTA-408 omaveloxolone Reata Pharmaceuticals Nrf2 activator Friedreich's ataxia PO InTrial 2021 Yes Yes
neurokinin 1 receptor LY-686017 tradipitant Vanda Pharmaceuticals Motion sickness PO InTrial 2021 No No (NK-1R) antagonist
CastiaRx.com // p: 866.516.2121 20 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
sodium-dependent glucose transporter 1 Zynquista sotagliflozin Sanofi/ Lexicon Diabetes mellitus PO CRL 2021 No No (SGLT-1) and SGLT-2 inhibitor
IgG1 monoclonal PRO-145223 etrolizumab Genentech Ulcerative colitis SC InTrial 2021 Yes No antibody
Ophthalmological DS-100 DS-100 Eton undisclosed SC InTrial 2021 Yes No disease ublituximab (LFB-R603, Chronic lymphocytic TG20, TGTX- 1101, TG- CD-20 monoclonal ublituximab TG Therapeutics leukemia/ multiple IV InTrial 2021 Yes Yes 1101, antibody sclerosis Utuxin)
S5G4T-1 benzoyl peroxide Sol-Gel Technologies benzoyl peroxide Rosacea TOP InTrial 2021 No No
estrogen receptor Estelle estetrol/ drospirenone Mithra Pregnancy prevention PO InTrial 2021 No No agonist
hypoxia-inducible factor- AKB-6548 vadadustat Akebia Therapeutics prolyl hydroxylase (HIF- Anemia PO InTrial Late 2021 Yes No PH) inhibitor
paroxysmal nocturnal hemoglobinuria; Ultomiris SC ravulizumab-cwvz Alexion C5 complement inhibitor SC InTrial Late 2021 Yes Yes Hemolytic uremic syndrome
etranacogene AMT-061 uniQure gene therapy Hemophilia B IV InTrial Late 2021 Yes No dezaparvovec
CaPre omega-3 fatty acids Acasti Pharma fatty acids Hypertriglyceridemia PO InTrial Late 2021 No No
CastiaRx.com // p: 866.516.2121 21 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
multivalent group B PF-06482077 Pfizer vaccine Bacterial infection IM InTrial Late 2021 Yes No streptococcus vaccine
GS-010 GS-010 GenSight Biologics gene therapy Optic neuropathy Intraocular InTrial Late 2021 Yes Yes
Fungal infections, ATI-1501 metronidazole Appili Therapeutics nitroimidazole anaerobic bacterial PO InTrial Late 2021 No No infections
digoxin immune fab digitalis-like factor AMAG-423 AMAG/ Velo Preeclampsia IV InTrial Late 2021 Yes Yes (DIF) antagonist
RGN-259 (GBT- 201; RGN- timbetasin RegeneRx actin regulating peptide Dry eyes OP InTrial Late 2021 No Yes 352)
COR-003 levoketoconazole Strongbridge Biopharma azole antifungal Cushing's syndrome PO InTrial Late 2021 No Yes
DNA-directed DNA CMX-001 brincidofovir Chimerix Smallpox PO InTrial Late 2021 No Yes polymerase inhibitor
Wet age-related macular PDS-1.0 ranibizumab Roche/ Genentech anti-VEGF antibody Intravitreal implant InTrial Late 2021 Yes No degeneration
Duchenne muscular CAT-1004 edasalonexent Catabasis NF-kB inhibitor PO InTrial Late 2021 Yes Yes dystrophy
tripotassium citrate monohydrate/ Distal rental tubular ADV-7103 Advicenne undisclosed PO InTrial Late 2021 Yes No potassium hydrogen acidosis carbonate
wet age-related macular ONS-5010 bevacizumab Outlook Therapeutics anti-VEGF antibody Intravitreal InTrial Late 2021 Yes No degeneration
CastiaRx.com // p: 866.516.2121 22 Brand Pipeline Forecast 1st Quarter 2020
Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug
glatiramer acetate long- glatiramer acetate depot Mylan/ Mapi Pharma immunosuppressant Multiple sclerosis IM InTrial Late 2021 Yes No acting
insulin-like growth factor NNZ-2566 trofinetide Neuren Rett syndrome IV/PO InTrial Late 2021 Yes Yes 1 (IGF-1) derivative
allosteric Bcr-Abl Chronic myelogenous ABL-001 asciminib Novartis PO InTrial Late 2021 Yes Yes inhibitor leukemia
apical sodium- dependent bile acid SHP-625 (LUM- 001) maralixibat Mirum Pharmaceuticals Alagille syndrome PO InTrial Late 2021 Yes Yes transporter (ABST) inhibitor
angiopoietin-like 3 REGN-1500 evinacumab Regeneron Hyperlipidemia IV/SC InTrial Late 2021 Yes No (ANGPTL3) antagonist
Adenosine deaminase- ADA-transduced deficient severe OTL-101 autologous stem cell Orchard Therapeutics gene therapy INJ InTrial Late 2021 Yes Yes combined therapy immunodeficiency
Mitsubishi Tanabe Erythropoietic MT-7117 MT-7117 Undisclosed PO InTrial Late 2021 Yes No Pharma protoporphyria 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 23