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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Revelation Biosciences | REVTx 99 | COVID-19 | phase 1 study approved by the Therapeutic Goods Administration of Australia |
| Noxopharm | Veyonda | COVID-19 patients hospitalized with moderate lung dysfunction requiring low oxygen support who are at risk of progressing rapidly into requiring intensive care and mechanical ventilation | first patient treated in phase 1 trial |
| Arch Biopartners | Metablok (LSALT peptide) | acute lung injury and acute kidney injury caused by inflammation in patients with moderate-to-severe cases of COVID-19 | initiation of phase 2 trial approved by Turkey’s Ministry of Health |
| Vir Biotechnology GlaxoSmithKline |
VIR-7831/GSK4182136 | early treatment of COVID-19 in patients who are at high risk of hospitalization | initiation of phase 3 portion of phase 2/3 trial |
| Dascena | COViage (Hemodynamic Instability and Respiratory Decompensation Prediction System) | adult patients with confirmed COVID-19 to assist with the early identification of patients likely to experience hemodynamic instability or respiratory decompensation | Emergency Use Authorization (EUA) granted by the FDA |
| LabCorp | COVID-19 molecular test | diagnosis of COVID-19 | EUA granted by the FDA |
| Other Trials and Actions | |||
| Fulcrum Therapeutics | FTX-6058 | sickle cell disease | initiation of phase 1 trial |
| Stoke Therapeutics | STK-001 | Dravet syndrome in children and adolescents | approved for additional dose level in phase 1/2a trial |
| AiViva Biopharma | AIV001 | superficial or nodular basal cell carcinoma | initiation of phase 1/2 trial |
| Arch Oncology | AO-176 in combination with paclitaxel | gastric, endometrial and platinum-resistant ovarian cancers | initiation of phase 2 portion of phase 1/2 trial |
| Eureka Therapeutics | ET140203 ARTEMIS T cell therapy | hepatocellular carcinoma | initiation of phase 1/2 trial |
| Histogen | HST-001 | androgenic alopecia in men | completion of patient dosing in phase 1/2 trial |
| Mustang Bio | MB-102 | relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia and high-risk myelodysplastic syndrome | first patient dosed in phase 1/2 trial |
| NexImmune | NEXI-002 | multiple myeloma | first patient dosed in phase 1/2 trial |
| Cerevel Therapeutics | CVL-865 | adults with drug-resistant focal onset seizures | first patient dosed in phase 2 trial |
| Kyowa Kirin MEI Pharma |
zandelisib (ME-401) | indolent B-cell nonHodgkin's lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström's macroglobulinemia | first patient dosed in phase 2 trial |
| Neurotrope | Bryostatin-1 | Alzheimer's disease | first patient dosed in phase 2 trial |
| Windtree Therapeutics | istaroxime | early cardiogenic shock in heart failure patients | first patient dosed in phase 2 trial |
| Arena Pharma | olorinab | abdominal pain in irritable bowel syndrome | patient enrollment complete in phase 2b trial |
| Imago Biosciences | bomedemstat (IMG-7289) | essential thrombocythemia | first patient dosed in phase 2b trial |
| Athira Pharma | ATH-1017 | mild-to-moderate Alzheimer's disease | first patients dosed in phase 2/3 trial |
| Tarsus Pharmaceuticals | TP-03 | Demodex blepharitis | first patients enrolled in phase 2b/3 trial |
| Napo Pharmaceuticals | Mytesi (crofelemer) | cancer therapy-related diarrhea | initiation of phase 3 trial |
| Brickell Biotech | sofpironium bromide gel, 15% | primary axillary (underarm) hyperhidrosis | initiation of phase 3 trial |
| Debiopharm | xevinapant | locally advanced squamous cell carcinoma of the head and neck | initiation of phase 3 trial |
| Achieve Life Sciences | cytisinicline | smoking cessation | initiation of phase 3 trial |
| Pfizer Sangamo Therapeutics |
giroctocogene fitelparvovec (SB-525) | hemophilia A | first patient dosed in phase 3 trial |
| Phasebio Pharmaceuticals | bentracimab | reversal of the antiplatelet effects of Brilinta (ticagrelor) | first patient dosed in new Canadian arm of phase 3 trial |
| Kodiak Sciences | KSI-301 | treatment-naïve patients with diabetic macular edema and macular edema due to retinal vein occlusion | first patients dosed in three phase 3 trials |
| Otonomy | Otividex | Ménière’s disease | patient enrollment complete in phase 3 trial |
| Teneobio | TNB-486 | B-cell nonHodgkin’s lymphoma | IND approved by the FDA |
| Pulse Biosciences | CellFX System | sebaceous hyperplasia lesions | Investigational Device Exemption approved by the FDA |
| AstraZeneca | Farxiga (dapagliflozin) | chronic kidney disease with and without type 2 diabetes | Breakthrough Therapy designation granted by the FDA |
| Immunogen | IMGN632 | relapsed or refractory blastic plasmacytoid dendritic cell neoplasm | Breakthrough Therapy designation granted by the FDA |
| Aegle Therapeutics | AGLE-102 | dystrophic epidermolysis bullosa | Fast-Track designation granted by the FDA |
| BioMarin | BMN 307 | phenylketonuria | Fast-Track designation granted by the FDA |
| Pfizer | PF-06939926 | Duchenne muscular dystrophy | Fast-Track designation granted by the FDA |
| CARsgen | CT041 | gastric and gastroesophageal junction adenocarcinoma | Orphan Drug designation granted by the FDA |
| Eyevensys | EYS611 | retinitis pigmentosa | Orphan Drug designation granted by the FDA |
| Aegle Therapeutics | AGLE-102 | dystrophic epidermolysis bullosa | Rare Pediatric Disease designation granted by the FDA |
| Bristol-Myers Squibb | Opdivo (nivolumab) plus Yervoy (ipilimumab) | unresectable malignant pleural mesothelioma | approved by the FDA for expanded indication |
| Johnson & Johnson | Thermocool Smarttouch SF Ablation Catheter | persistent atrial fibrillation | approved by the FDA |
| SurGenTec | 3D GraftRasp System | decortication of bone and the delivery of autograft, allograft or synthetic bone graft | approved by the FDA |
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