The table below is a review of notable updates that occurred in December 2022 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Drug Pharmacologic Class Proposed Indication Status
Cardiovascular Disease
Omecamtiv mecarbil (Cytokinetics) Selective small molecule cardiac myosin activator Treatment of heart failure with reduced ejection failure. FDA panel voted
Dermatological Disorders
Bimekizumab (UCB) Humanized monoclonal IgG1 antibody that inhibits IL-17A and IL-17F Treatment of adults with moderate to severe plaque psoriasis. Resubmitted BLA accepted for review
Gastrohepatic Disorders
Etrasimod (Pfizer)  Oral selective sphingosine 1-phosphate receptor modulator Treatment of patients with moderately to severely active ulcerative colitis. NDA accepted for review
Immunization
mRNA-based combination vaccine (Pfizer and BioNTech) modRNA-based influenza vaccine candidate + Omicron-adapted bivalent COVID-19 vaccine For the prevention of influenza and COVID-19 with a single injection. Fast Track designation
Pentavalent meningococcal vaccine (MenABCWY; Pfizer) Meningococcal vaccine candidate For the prevention of invasive meningococcal disease caused by serogroups A, B, C, W and Y in individuals 10 through 25 years of age. BLA accepted for review
RSVpreF (PF-06928316; Pfizer) Bivalent RSV vaccine candidate For the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older. BLA accepted for Priority Review
Infectious Diseases
Olorofim (F2G Inc.) Orotomides – new class of antifungal agents targeting the de novo pyrimidine biosynthesis pathway. Treatment of invasive fungal infections in patients who have limited or no treatment options. NDA accepted
Metabolic Disorders
Bitopertin (Disc Medicine) Glycine transporter 1 inhibitor Treatment of erythropoietic protoporphyria. Orphan Drug designation
Pegunigalsidase alfa (Protalix BioTherapeutics and Chiesi Global Rare Diseases) Long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate Treatment of adults with Fabry disease. Orphan Drug designation
Oncology
Omburtamab (Y-mAbs)  Radiolabeled monoclonal antibody targeting tumor cells that express B7-H3 Treatment of CNS/leptomeningeal metastasis from neuroblastoma. Complete Response Letter issued
WP1122 (Moleculin)  Prodrug of 2-DG targeting glycolysis and glycosylation Treatment of glioblastoma multiforme. Fast Track designation
ZB131 (ZielBio) Monoclonal antibody targeting cancer-specific plectin Treatment of pancreatic cancer. Fast Track designation
Ophthalmic Disorders
ADX-2191 (methotrexate injection; Aldeyra Therapeutics) DMARD (folic acid antagonist). Intravitreal formulation designation to be vitreous-compatible. Treatment of primary vitreoretinal lymphoma. NDA submitted
Poisoning & Drug Dependence
Brixadi (buprenorphine extended-release injection; Braeburn) Opioid (partial agonist-antagonist) Weekly and monthly subcutaneous injection for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Resubmitted NDA accepted for review
Narcan (OTC naloxone HCI nasal spray; Emergent BioSolutions) Opioid antagonist that reverses the effects of opioids For the OTC emergency treatment for opioid overdose. sNDA accepted for Priority Review
RiVive (OTC naloxone HCI nasal spray; Harm Reduction Therapeutics) Opioid antagonist that reverses the effects of opioids For the OTC emergency treatment for opioid overdose. NDA accepted for Priority Review
Psychiatric Disorders
PH10 (pherine nasal spray; Vistagen) Binds to peripheral chemosensory neurons in nasal passages to regulate the olfactory-amygdala neural circuits Treatment of major depressive disorder. Fast Track designation