The table below is a review of notable updates that occurred in July 2022 for investigational products in development (not an inclusive list). Click on the status link to view our full coverage.
| Drug | Pharmacologic Class | Proposed Indication | Status |
| Cardiovascular Disease | |||
| Abelacimab (Anthos Therapeutics) | Novel Factor XI inhibitor | Treatment of thrombosis associated with cancer. | Fast Track designation |
| Sotagliflozin (Lexicon Pharmaceuticals) | Dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor | Treatment of heart failure. | NDA accepted for review |
| Dermatological Disorders | |||
| Vilobelimab (InflaRx N.V.) | Anti-human complement factor C5a monoclonal antibody | Treatment of ulcerative pyoderma gangrenosum. | Fast Track designation |
| Endocrine Disorders | |||
| MBX 2109 (MBX Biosciences, Inc.) | Long-acting parathyroid hormone prodrug | Treatment of hypoparathyroidism. | Orphan Drug designation |
| Teplizumab (Provention Bio, Inc.) | Anti-CD3 monoclonal antibody | Delay of clinical type 1 diabetes in at-risk individuals. | FDA extended review period for BLA |
| Gastrohepatic Disorders | |||
| Rinvoq (upadacitinib; AbbVie) | Janus kinase inhibitor | Treatment of adults with moderately to severely active Crohn disease. | NDA submitted |
| Hematological Disorders | |||
| KP104 (Kira Pharmaceuticals) | Bifunctional antibody fusion protein | Treatment of paroxysmal nocturnal hemoglobinuria. | Orphan Drug designation |
| Infectious Diseases | |||
| PLG0206 (Peptilogics) | Broad-spectrum, anti-biofilm, anti-infective peptide therapeutic | Treatment of periprosthetic joint infection. | Fast Track designation |
| Neurologic Disorders | |||
| Lecanemab (Eisai Co., Ltd.) | Anti-amyloid beta protofibril antibody | Treatment of mild cognitive impairment due to Alzheimer disease and early Alzheimer disease with confirmed presence of amyloid pathology in the brain. | BLA accepted for Priority Review |
| Tofersen (Ionis Pharmaceuticals, Inc.) | Antisense drug that reduces synthesis of superoxide dismutase 1 (SOD1) protein | Treatment of superoxide dismutase 1 amyotrophic lateral sclerosis (SOD1-ALS). | NDA accepted for Priority Review |
| Trofinetide (Acadia Pharmaceuticals Inc.) | Novel synthetic analogue of the amino-terminal tripeptide of IGF-1 | Treatment of Rett syndrome in patients 2 years of age and older. | NDA submitted |
| Oncology | |||
| DSP-0390 (Sumitomo Pharma Oncology) | Inhibitor of emopamil-binding protein | Treatment of high-grade glioma. | Orphan Drug Designation |
| Enhertu (fam-trastuzumab deruxtecan-nxki; AstraZeneca and Daiichi Sankyo) | HER2-directed antibody and topoisomerase inhibitor conjugate | Treatment of adults with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridization [ISH]-negative) breast cancer who have received a prior therapy in the metastatic setting. | sBLA accepted for Priority Review |
| [Vic-] trastuzumab duocarmazine (SYD985; Byondis B.V.) | Anti-HER2 antibody-drug conjugate | Treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer. | BLA accepted for review |
| Vicineum (oportuzumab monatox-qqrs; Sesen Bio) | Recombinant fusion protein targeting epithelial cell adhesion molecule antigens to deliver Pseudomonas Exotoxin A | Treatment of bacillus-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer. | Clinical development paused |
| Ophthalmic Disorders | |||
| Pegcetacoplan (Apellis Pharmaceuticals, Inc.) | Intravitreal targeted complement C3 therapy | Treatment of geographic atrophy. | NDA accepted for Priority Review |
| Pain Management | |||
| VX-548 (Vertex Pharmaceuticals Inc.) | Selective NaV1.8 inhibitor | Treatment of moderate to severe acute pain. | Breakthrough Therapy designation |
