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Drug & Device Pipeline News
This week’s Pipeline features a phase 2 trial approval for bipolar disorder, a phase 3 trial initiation for advanced metastatic breast cancer, and an FDA drug approval for major depressive disorder.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Antibe Therapeutics | Otenaproxesul | Acute pain | IND for a phase 1 trial approved by Health Canada |
Cabaletta Bio | CABA-201 | Systemic sclerosis | IND for a phase 1/2 trial approved by the FDA |
Akeso | AK117 | Newly diagnosed higher-risk myelodysplastic syndromes | IND for a phase 2 trial approved by the FDA |
MAIA Biotechnology | THIO | Advanced non-small cell lung cancer | IND for a phase 2 trial approved by the FDA |
Alzamend Neuro | AL001 | Bipolar disorder | IND for a phase 2 trial approved by the FDA |
Transcenta | Osemitamab | First-line gastric/gastroesophageal cancer | IND for a phase 3 trial approved by the FDA |
ReGelTec | HYDRAFIL System | Chronic low back pain due to degenerative disc disease | IDE approved by the FDA |
Trials Initiated | |||
Gain Therapeutics | GT-02287 | Parkinson’s disease | Initiation of a phase 1 trial |
HanchorBio | HCB101 | Advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma | Initiation of a phase 1 trial |
ImmunoGenesis | IMGS-001 | Relapsed/refractory advanced solid tumors | Initiation of a phase 1a/1b trial |
Synthekine | STK-012 | Solid tumors including renal cell carcinoma and non-small cell lung cancer | Initiation of phase 1b portion of phase 1a/1b trial |
Starton Therapeutics | STAR-LLD (low-dose lenalidomide) | Multiple myeloma | Initiation of a phase 1b trial |
Clarity Pharmaceuticals | 64Cu/67Cu SAR-Bombesin | Metastatic castration-resistant prostate cancer | Initiation of a phase 1/2 trial |
Moleculin Biotech | Annamycin plus cytarabine | Acute myeloid leukemia | Initiation of phase 2 portion of phase 1b/2 trial |
Mabwell | 9MW2821 plus PD-1 inhibitor | Locally advanced or metastatic urothelial carcinoma | Initiation of a phase 1b/2 trial in Europe |
Vedanta Biosciences | VE202 | Ulcerative colitis | Initiation of a phase 2 trial |
Agomab Therapeutics | AGMB-129 | Fibrostenosing Crohn’s disease | Initiation of a phase 2a trial |
Boehringer Ingelheim Zealand Pharma |
Survodutide | Obese or overweight people with comorbidities but not type 2 diabetes | Initiation of a phase 3 trial |
Boehringer Ingelheim Zealand Pharma |
Survodutide | Obese or overweight people with comorbidities including type 2 diabetes | Initiation of a phase 3 trial |
Boehringer Ingelheim Zealand Pharma |
Survodutide | Obese or overweight people with cardiovascular disease or chronic kidney disease | Initiation of a phase 3 trial |
BriaCell Therapeutics | Bria-IMT plus an immune checkpoint inhibitor | Advanced metastatic breast cancer | Initiation of a phase 3 trial |
Approvals | |||
Amicus Therapeutics | Pombiliti (cipaglucosidase alfa-atga) plus Opfolda (miglustat) | Late-onset Pompe disease | Approved by the FDA |
Fabre-Kramer Pharmaceuticals | Exxua (gepirone hydrochloride extended-release tablets) | Major depressive disorder in adults | Approved by the FDA |
Novo Nordisk | Rivfloza (nedosiran) injection | Patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | Approved by the FDA |
Apellis Pharmaceuticals | Empaveli (pegcetacoplan) Injector | Paroxysmal nocturnal hemoglobinuria | Approved by the FDA |
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14Apr