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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Ampio Pharmaceuticals | Ampion | respiratory distress due to COVID-19 | IND approved by the FDA |
| DURECT | DUR-928 | hospitalized COVID-19 patients with acute liver or kidney injury | first patient dosed in phase 2 trial |
| Rigel Pharmaceutical | fostamatinib | hospitalized COVID-19 patients | initiation of phase 2 trial |
| Johnson & Johnson/Janssen | JNJ-78436735 (COVID-19 vaccine) | COVID-19 | initiation of phase 3 trial |
| Vela Diagnostics | ViroKey SARS-CoV-2 RT-PCR Test v2.0 | COVID-19 detection | Emergency Use Authorization granted by the FDA |
| Other Trials and Actions | |||
| Advaxis | ADXS-504 | prostate cancer | IND approved by the FDA |
| American Cryostem | ATCell, expanded autologous adipose-derived mesenchymal stem-cell therapy | postconcussion syndrome | IND approved by the FDA |
| Athenex | TCRT-ESO-A2, autologous T cell receptor - T cell therapy | solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients | IND approved by the FDA |
| Genocea Biosciences | GEN-011 | patients with solid tumors who have failed standard-of-care checkpoint inhibitor therapy | IND approved by the FDA |
| Morphosys I-Mab |
MOR210/TJ210 | relapsed or refractory advanced solid tumors | IND approved by the FDA |
| Cytokinetics | CK-3772271 | hypertrophic cardiomyopathy | first patient dosed in phase 1 trial |
| InMed Pharmaceuticals | INM-755 | epidermolysis bullosa | dosing complete in phase 1 trial |
| Jasper Therapeutics | JSP191 | patients with myelodysplastic syndromes and acute myeloid leukemia who are undergoing blood or hematopoietic cell transplantation | first patient dosed in phase 1 trial |
| Millendo Therapeutics | MLE-301 | vasomotor symptoms in menopausal women | first patient dosed in phase 1 trial |
| Morphic Therapeutic | MORF-057 | inflammatory bowel disease | first patient dosed in phase 1 trial |
| BioMarin | BMN 307 | phenylketonuria | first patient dosed in phase 1/2 trial |
| Neximmune | NEXI-001 | acute myeloid leukemia | dosing complete in first cohort of phase 1/2 trial |
| BridgeBio/Calcilytix Therapeutics | encaleret (CLTX-305) | autosomal dominant hypocalcemia Type 1 (ADH1) | initiation of phase 2 trial |
| Calithera | elaglenastat (CB-839) in combination with pembrolizumab, carboplatin and pemetrexed | stage IV non-squamous NSCLC whose tumors have a KEAP1 or NRF2 mutation | first patient randomized in phase 2 trial |
| Frequency Therapeutics | FX-322 | sensorineural hearing loss | patient enrollment complete in phase 2a trial |
| Intensity Therapeutics | INT230-6 in combination with Yervoy (ipilimumab) | breast cancer, liver cancer and sarcoma | first patient dosed in phase 2 trial |
| Lipocine | LPCN 1144 | non-cirrhotic non-alcoholic steatohepatitis | last patient enrolled in phase 2 trial |
| MiMedx | micronized injectable amniotic tissue | osteoarthritis of the knee | phase 2b trial complete |
| Nordic Bioscience Clinical Development AKL Research and Development |
AAPA | osteoarthritis | first patient enrolled in phase 2 trial |
| Principia Biopharma | rilzabrutinib | IgG4-related disease | first patient dosed in phase 2a trial |
| Cortexyme | atuzaginstat (COR388) | mild to moderate Alzheimer’s disease | patient enrollment complete in phase 2/3 trial |
| MiMedx | micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection | plantar fasciitis | patient enrollment complete in phase 3 trial |
| Swedish Orphan Biovitrum Selecta Bioscience |
SEL-212 | chronic refractory gout | first patient randomized in phase 3 trial |
| Athersys | MultiStem cell therapy | Acute Respiratory Distress Syndrome (ARDS) | Regenerative Medicine Advanced Therapy designation granted by the FDA |
| Medeor Therapeutics | MDR-101 | immune tolerance in kidney transplant recipients | Regenerative Medicine Advanced Therapy designation granted by the FDA |
| Gyroscope Therapeutics | GT005 | geographic atrophy secondary to dry age-related macular degeneration | Fast-Track designation granted by the FDA |
| Leap Therapeutics | DKN-01 | patients with gastric and gastroesophageal junction adenocarcinoma tumors with DKK1 expression, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate HER2/neu-targeted therapy | Fast-Track designation granted by the FDA |
| Innova Therapeutics | IVT-8086 | osteosarcoma | Rare Pediatric Disease designation granted by the FDA |
| Mereo Biopharma | setrusumab | osteogenesis imperfecta | Rare Pediatric Disease designation granted by the FDA |
| Baxter International | Clinimix (amino acids in dextrose) and Clinimix E (amino acids with electrolytes in dextrose and calcium) injections | patients requiring parenteral nutrition | FDA approved for new formulations |
| Surmodics | Pounce Thrombus Retrieval System | nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature | FDA approved |
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