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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Nektar Therapeutics | bempegaldesleukin (NKTR-214) | adults diagnosed with mild COVID-19 infection | IND approved by the FDA for phase 1b trial |
| Nitric Oxide Innovations | NOviricid, 30 mg sodium nitrite oral lozenge | African Americans diagnosed with COVID-19 | IND approved by the FDA for phase 2b/3 trial |
| Ampio Pharmaceuticals | inhaled Ampion added to the standard of care | COVID-19 infected patients hospitalized for respiratory distress | initiation of phase 1 trial |
| HiFiBiO Therapeutics | HFB30132A | treatment and prevention of COVID-19 | dosing complete in first cohort of phase 1 trial |
| aTyr Pharma | ATYR1923 | COVID-19 patients with severe respiratory complications | patient enrollment complete in phase 2 trial |
| Boehringer Ingelheim | BI 764198 | patients hospitalized with SARS-CoV-2 with severe respiratory complications | initiation of phase 2 trial |
| Immutep | eftilagimod alpha (IMP321) | hospitalized patients with COVID-19 | initiation of phase 2 trial |
| Olatec Therapeutics | dapansutrile capsules | patients with moderate COVID-19 symptoms and evidence of early Cytokine Release Syndrome | initiation of phase 2 trial |
| ANA Therapeutics | oral niclosamide (ANA001) | patients with moderate COVID-19 | initiation of phase 2/3 trial |
| Biophytis SA | Sarconeos (BIO101) | patients with COVID-19-related respiratory failure | first patient enrolled in Brazil in phase 2/3 trial |
| AstraZeneca | AZD1222 | COVID-19 vaccine | U.S portion of phase 3 trial resumed |
| Moderna | mRNA-1273 | COVID-19 vaccine | patient enrollment complete in phase 3 trial |
| Agena Bioscience | assARRAY SARS-CoV-2 Panel | qualitative detection of the SARS-CoV-2 coronavirus | Emergency Use Authorization (EUA) granted by the FDA |
| Gilead Sciences | Veklury (remdesivir) | patients with COVID-19 requiring hospitalization | approved by the FDA |
| Other Trials and Actions | |||
| ATAI Life Sciences | Neuronasal (intranasal delivery of low doses of N-acetylcysteine) | acute mild traumatic brain injury | IND approved by FDA |
| BioXcel Therapeutics | BXCL501 | agitation associated with delirium | IND approved by the FDA |
| Insignis Therapeutics HLK Pharmacin |
N-001(oral epinephrine prodrug) | allergic reactions, including anaphylaxis | IND approved by the FDA |
| Vanda Pharmaceuticals | VSJ-110 | allergic conjunctivitis | IND approved by the FDA |
| Y-mAbs Therapeutics | 177Lu-omburtamab-DTPA | B7-H3 positive central nervous system and leptomeningeal metastasis tumors | IND approved by the FDA |
| Asieris Pharmaceuticals | APL-1501 | bladder cancer, urinary tract infection | clinical trial approved in Australia |
| BioInvent International | BI-1808 | ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma | clinical trial approved in Europe |
| Exelixis | XL092 alone and in combination with atezolizumab (Tecentriq) | advanced solid tumors | first patient enrolled in phase 1 trial |
| Plus Therapeutics | Rhenium NanoLiposomes | recurrent glioblastoma | first patient treated in final cohort of phase 1 trial |
| Genome & Company | GEN-001 | solid tumors | first patient dosed in phase 1/1b trial |
| Gmax Biopharm | GMA301 | pulmonary arterial hypertension | first patient dosed in phase 1b trial |
| ImmunoMolecular Therapeutics | IMT-002 | patients with HLA-DQ8 positive type 1 diabetes | initiation of phase 1b trial |
| ALX Oncology | ALX148 | higher-risk myelodysplastic syndrome | first patient dosed in the phase 1/2 trial |
| HOOKIPA Pharma | HB-202/HB-201 alternating vector therapy | human papillomavirus 16-positive (HPV16+) cancers | first patient dosed in phase 1/2 trial |
| Oncolytis Biotech Roche |
pelareorep plus atezolizumab (Tecentriq) | metastatic pancreatic and colorectal and advanced anal cancers | initiation of phase 1/2 trial |
| Syntrix Pharmaceuticals | SX-682 | myelodysplastic syndromes and metastatic melanoma | patient dosing complete in phase 1/2 trial |
| Arcutis Biotherapeutics | ARQ-252 | adults with chronic hand eczema | patient enrollment complete in phase 1b/2 trial |
| Sumitomo Dainippon Pharma Oncology | dubermatinib (TP-0903) plus decitabine | patients 60 years or older with newly diagnosed acute myeloid leukemia with TP53 mutations and/or complex karyotype | first patient dosed in phase 1b/2 trial |
| Annovis Bio | ANVS401 | early Alzheimer’s disease | patient enrollment resumed following suspension of phase 2 trial due to COVID-19 |
| BioLineRx | motixafortide | first-line metastatic pancreatic ductal adenocarcinoma | initiation of phase 2 trial |
| Novartis | NIS793 | first-line metastatic pancreatic ductal adenocarcinoma | initiation of phase 2 trial |
| PDS Biotech | PDS0101 | locally advanced cervical cancer | initiation of phase 2 trial |
| Phosplatin Therapeutics | PT-112 | metastatic castration-resistant prostate cancer | first patient dosed in phase 2 trial |
| Aerie Pharmaceuticals | AR-15512 | dry eye disease | initiation of phase 2b trial |
| PTC Therapeutics | vatiquinone (PTC743) | mitochondrial epilepsy | initiation of phase 2/3 trial |
| Castle Creek Biosciences | debcoemagene autofice (FCX-007) | recessive dystrophic epidermolysis bullosa | first patient dosed in phase 3 trial |
| Innate Pharma AstraZeneca |
monalizumab plus cetuximab | recurrent or metastatic squamous cell carcinoma of the head and neck in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors | first patient dosed in phase 3 trial |
| MediWound | NexoBrid | hospitalized children with severe thermal burns | patient enrollment complete in phase 3 trial |
| Polyphor | balixafortide | metastatic breast cancer | patient enrollment complete in phase 3 trial |
| Prilenia Therapeutics | pridopidine | patients with early stage Huntington’s disease | first patients enrolled in phase 3 trial |
| RegeneRx ReGenTree |
0.1% RGN-259 eye drops | dry eye syndrome | last patient enrolled in phase 3 trial |
| Prevail Therapeutics | PR001 | neuronopathic Gaucher disease | Fast-Track designation granted by the FDA |
| Passage Bio | PBKR03 | Krabbe disease (Globoid Cell Leukodystrophy) | Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA |
| reVision Therapeutics | REV-0100 | Stargardt disease | Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA |
| Taysha Gene Therapies | TSHA-104 | SURF1-associated Leigh syndrome | Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA |
| Adaptive Phage Therapeutics | PhageBank | prosthetic joint infections | Orphan Drug designation granted by the FDA |
| Kezar Life Sciences | KZR-616 | polymyositis and dermatomyositis | Orphan Drug designation granted by the FDA |
| Cala Health | Cala Trio | action tremors in the hands of adults with Parkinson’s disease | Breakthrough Device designation granted by the FDA |
| Abiomed | Abiomed Breethe OXY-1 System | cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation | approved by the FDA |
| Bayer | FoundationOneCDx | companion diagnostic for Vitrakvi (larotrectinib) to help identify NTRK gene fusion-positive patients | approved by the FDA |
| Kala Pharmaceuticals | Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% | short-term (up to two weeks) treatment for dry eye disease | approved by the FDA |
| Medtronic | Abre venous self-expanding stent system | use in the iliofemoral veins in patients with symptomatic deep venous obstruction | approved by the FDA |
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