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