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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Airway Therapeutics | AT-100 (rhSP-D) | severe COVID-19 | IND approved by the FDA |
| Resverlogix | apabetalone | treatment of patients hospitalized with COVID-19 | clinical trial approved by Health Canada |
| Akston Biosciences | AKS-452 vaccine | COVID-19 | initiation of phase 1/2 trial |
| Kinarus AG | KIN001 | treatment of patients hospitalized with COVID-19 | first patient dosed in phase 2 trial |
| Lucira Health | LUCIRA CHECK IT at-home test kit | COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| Other Trials and Actions | |||
| Axcella | AXA1125 | nonalcoholic steatohepatitis | IND approved by the FDA |
| Kibow Biotech | APR2020 | chronic kidney disease, stage IV | IND approved by the FDA |
| Neuraptive Therapeutics | NTX-001 | treatment and prevention of facial paralysis requiring surgical repair | IND approved by the FDA |
| NervGen Pharma | NVG-291 | nerve damage and neurodegenerative diseases | clinical trial approved in Australia |
| LintonPharm | catumaxomab | nonmuscle-invasive bladder cancer with recurrent tumors due to Bacillus Calmette-Guerin (BCG) vaccine failure | phase 1/2 trial approved by China’s National Medical Products Administration |
| Agenus Therapeutics | agenT-797 | hematologic cancers | first patient dosed in phase 1 trial |
| Allogene Therapeutics SpringWorks Therapeutics |
ALLO-715 in combination with nirogacestat | relapsed or refractory multiple myeloma | first patient dosed in phase 1 trial |
| Cofactor Genomics | OncoPrism diagnostic assay | recurrent and metastatic squamous cell carcinoma of the head and neck | initiation of phase 1 trial |
| Gannex/Ascletis Pharma | ASC41 | nonalcoholic fatty liver disease | first cohort dosed in phase 1 trial |
| Ideaya Biosciences | IDE397 | treatment of cancer patients harboring methylthioadenosine phosphorylase deletion | first patient dosed in phase 1 trial |
| Rubius Therapeutics | RTX-321 | human papilloma virus 16-positive cancers | first patient dosed in phase 1 trial |
| Peptilogics | PLG0206 | prosthetic joint infections | completion of phase 1 trial |
| Regulus Therapeutics | RGLS4326 | autosomal dominant polycystic kidney disease | dosing complete in first cohort of phase 1b trial |
| Artelo Biosciences | ART27.13 | cancer-related anorexia | first patient dosed in phase 1/2 trial |
| Longeveron | Lomecel-B | improvement of immune response to influenza vaccine in subjects with aging frailty | completion of phase 1/2 trial |
| Qlaris Bio | QLS-101 | reduction of episcleral venous pressure in patients with glaucoma | first patient enrolled in phase 1/2 trial |
| Turning Point Therapeutics | TPX-0131 | patients with locally advanced or metastatic TKI-pretreated ALK-positive nonsmall-cell lung cancer | initiation of phase 1/2 trial |
| REGENXBIO | RGX-121 | mucopolysaccharidosis Type II in patients up to age five | first patient dosed in cohort 3 of phase 1/2 trial |
| Synthetic Biologics | SYN-004 (ribaxamase) | allogeneic hematopoietic cell transplant recipients for the prevention of acute graft-versus-host-disease | first patient dosed in phase 1b/2a trial |
| InflaRx | vilobelimab | pyoderma gangraenosum | completion of patient enrollment in phase 2a trial |
| Antengene | ATG-008 (onatasertib) | advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations | first patient dosed in phase 2 trial |
| Boehringer Ingelheim Zealand Pharma |
BI 456906 | obesity in adults without diabetes | initiation of phase 2 trial |
| Boehringer Ingelheim Zealand Pharma |
BI 456906 | adults with nonalcoholic steatohepatitis and liver fibrosis (F2/F3) with and without diabetes | initiation of phase 2 trial |
| Connect Biopharma | CBP-201 | adult moderate-to-severe atopic dermatitis | patient enrollment complete in phase 2 trial |
| Arcutis Biotherapeutics | topical roflumilast cream (ARQ-151) | mild-to-moderate atopic dermatitis in patients between the ages of two and five | initiation of phase 3 trial |
| Adlai Nortye | buparlisib (AN2025) in combination with paclitaxel | recurrent or metastatic head and neck squamous cell carcinoma | first patient dosed in phase 3 trial |
| Akari Therapeutics | nomacopan | bullous pemphigoid | initiation of phase 3 trial |
| Geron | metelstat | refractory myelofibrosis | first patient dosed in phase 3 trial |
| Kyowa Kirin | tenapanor | hyperphosphatemia | initiation of four phase 3 trials |
| Myovant Sciences | elugolix once daily combination tablet | contraceptive in women age 18 to 35 | first patients dosed in phase 3 trial |
| Moleculin Biotech | WP1066 | ependymoma | Rare Pediatric Disease designation granted by the FDA |
| Akouos | AK-OTOF | otoferlin gene-mediated hearing loss | Rare Pediatric Disease and Orphan Drug designation granted by the FDA |
| Aprea Therapeutics | eprenetapopt | acute myeloid leukemia | Orphan Drug designation granted by the FDA |
| Cellularity | CYNK-001 | malignant gliomas | Orphan Drug designation granted by the FDA |
| MitoChem Therapeutics | MC16 | retinitis pigmentosa | Orphan Drug designation granted by the FDA |
| Syndax Pharmaceuticals | axatilimab | idiopathic pulmonary fibrosis | Orphan Drug designation granted by the FDA |
| vTv Therapeutics | TTP399 | type 1 diabetes | Breakthrough Therapy designation granted by the FDA |
| Gilead | Trodelvy (sacituzumab govitecan-hziy) | treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor | accelerated approval granted by the FDA |
| Novartis Genentech/Roche |
Xolair (omalizumab) prefilled syringe for self-injection | moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps | approved by the FDA for expanded formulation |
| Cosmo Pharmaceuticals | GI Genius intelligent endoscopy system | lesion detection during colonoscopy | approved by the FDA |
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