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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
AffaMed Therapeutics | AM71 | Retinal vascular diseases | IND approved by the FDA |
Citius Pharmaceuticals | Halo-Lido | Hemorrhoids | IND approved by the FDA |
Kairos Pharma | ENV105 | Prostate cancer | IND approved by the FDA |
Lexeo Therapeutics | LX2006 | Friedreich’s ataxia cardiomyopathy | IND approved by the FDA |
Noema Pharma | NOE-101 | Trigeminal neuralgia | IND approved by the FDA |
Kato Pharmaceuticals | Resolv ER | Vitreomacular attachment | IND approved by the FDA |
Neurocentria | NRCT-101SR | Adults with ADHD | Approval for a phase 2b/3 trial granted by the FDA |
Sirnaomics | STP707 | Primary sclerosing cholangitis | Safe-to-proceed letter issued by the FDA |
Asieris Pharmaceuticals | Hexvix | Nonmuscle-invasive bladder cancer | Approval for a phase 3 trial granted by China’s regulatory authority |
Trials Initiated | |||
Maze Therapeutics | MZE001 | Pompe disease | Initiation of phase 1 trial |
Enanta Therapeutics | EDP-235 | COVID-19 | Initiation of phase 1 trial |
Sumitovant Biopharma Sumitomo Dainippon Pharma |
KSP-1007 | Carbapenem-resistant bacterial infections | Initiation of phase 1 trial |
ZielBio | ZB131 | Solid tumors | Initiation of phase 1/2 trial |
Rakuten Shimadzu |
ASP-1929 | Head and neck squamous-cell carcinoma or cutaneous squamous-cell carcinoma | Initiation of phase 2 trial |
Resverlogix | Apabetalone | COVID-19 | Initiation of phase 2b trial in Brazil |
Laurent Pharmaceuticals | LAU-7b | Moderate-to-severe COVID-19 in hospitalized patients | Initiation of phase 2 portion of phase 2/3 trial |
Valbiotis | TOTUM-854 | High blood pressure | Initiation of two international phase 2/3 trials |
Kintor Pharmaceutical | Proxalutamide | COVID-19 treatment for outpatients | Initiation of phase 3 trial in China |
Approvals | |||
Lupin Pharmaceuticals | Solosec (secnidazole) | Bacterial vaginosis and trichomoniasis in adolescent females | Approval for expanded indication granted by the FDA |
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