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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Meiji Seika Pharma Co. | DMB-3115 | plaque psoriasis | Phase 1 trial initiated in healthy subjects at one site in Europe |
| Alligator Bioscience | ATOR-1017 | cancer | Phase 1 trial initiated dosing 50 subjects at three sites in Sweden |
| MODAG | anle138b | multiple system atrophy and Parkinson’s disease | Phase 1 trial initiated enrolling healthy subjects |
| Chondrial Therapeutics | CTI-1601 | Friedreich’s Ataxia | Phase 1 trial initiated dosing adult subjects over the age of 18 with Friedreich’s Ataxia |
| NeuClone Pharmaceuticals | ustekinumab | psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis | Phase 1 trial initiated dosing 210 subjects |
| Arcus Biosciences Genentech |
AB928, regorafenib, and atezolizumab | colorectal and pancreatic cancer | Phase 1/1b trial initiated in subjects with breast or ovarian cancer, gastroesophageal or colorectal cancer, lung cancer and advanced malignancies |
| OBI Pharma | OBI-999 | cancer | Phase 1/2 trial initiated enrolling subjects with solid tumors including gastric, pancreatic, colorectal and esophageal cancer at the University of Texas MD Anderson Cancer Center in Houston, Texas |
| Zentalis Pharmaceuticals | ZN-c3 | cancer | Phase 1/2 trial initiated dosing two subjects with advanced solid tumors |
| Akero Therapeutics | AKR-001 | non-alcoholic steatohepatitis | Phase 2 trial initiated enrolled 80 subjects with non-alcoholic steatohepatitis at multiple centers |
| DiaMedica Therapeutics | DM199 | chronic kidney disease | Phase 2 trial initiated dosing 60 African American subjects with hypertension and chronic kidney disease with IgA nephropathy |
| Catabasis Pharmaceuticals | edasalonexent | Duchenne muscular dystrophy | Phase 3 trial initiated enrolled 131 boys affected by Duchenne muscular dystrophy ages 4 to 7 with any mutation type whom had not been on steroids for the previous six months at 37 sites in the United States, Canada, Europe, Israel and Australia |
| Kamada | inhaled Alpha-1 Antitrypsin | Alpha-1 Antitrypsin Deficiency | Phase 3 trial initiated enrolling 250 subjects with AATD and moderate lung disease |
| Avadel Pharmaceuticals | FT218 | Narcolepsy | Phase 3 trial initiated enrolled 212 subjects with narcolepsy |
| Mycovia Pharmaceuticals | VT-1161 | recurrent vulvovaginal candidiasis | Phase 3 trial initiated enrolling 200 subjects with recurrent vulvovaginal candidiasis at 51 sites in the U.S. |
| Calliditas Therapeutics | Nefecon | IgA nephropathy | Phase 3 trial initiated enrolling 200 subjects with IgAN at approximately 140 sites in 19 countries |
| Innovation Pharmaceuticals | Brilacidin | ulcerative colitis | Clinical Trial Authorization acceptance granted by the MHRA |
| Pfizer | encorafenib in combination with cetuximab | colorectal cancer | sNDA granted by the FDA |
| ITF Pharma | TIGLUTIK | Amyotrophic Lateral Sclerosis | sNDA granted by the FDA |
| Amneal Pharmaceuticals | EluRyng | generic version of NuvaRing | aNDA granted by the FDA |
| Daré Bioscience | DARE-BV1 | bacterial vaginosis | IND approval granted by the FDA |
| Zentalis Pharmaceuticals | ZN-c3 | cancer | IND Approval granted by the FDA |
| Chondrial Therapeutics | CTI-1601 | Friedreich’s Ataxia | Fast-Track Designation and Rare Pediatric Disease Designation granted by the FDA |
| Salarius Pharmaceuticals | seclidemstat | Ewing sarcoma | Fast Track Designation granted by the FDA |
| Boston Scientific | EXALT Model D | single-use duodenoscope | Clearance granted by the FDA |
| Amarin Pharma | Vascepa | cardiovascular events | FDA approval granted |
| Pfizer | Xeljanz | ulcerative colitis | Approval granted by the FDA |
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