Drugs / OM336
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07229144 | Oct 2025 → Jun 2027 expected | Sjogren syndrome, idiopathic inflammatory myopathy | Lakefront Biotherapeutics West LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT07083960 | Aug 2025 → Dec 2026 expected | autoimmune hemolytic anemia, cold type, autoimmune hemolytic anemia, warm type, autoimmune thrombocytopenia | Lakefront Biotherapeutics West LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-01-23 | Keymed Biosciences Co.Ltd | Regulatory 康诺亚自主研发BCMA×CD3双抗CM336获美国FDA快速通道资格认定 keymedbio.com ↗
2026年1月23日，康诺亚和合作伙伴Ouro Medicines Ltd 共同宣布， BCMA×CD3双抗CM336（OM336）获得美国食品药品监督管理局（FDA）授予的快速通道资格（Fast Track Designation, FTD）认定， 用于治疗自身免疫性溶血性贫血（AIHA）和免疫性血小板减少症（ITP） 。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-01-23 | Keymed Biosciences Co.Ltd | 康诺亚自主研发BCMA×CD3双抗CM336获美国FDA快速通道资格认定 keymedbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OM336 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07229144 ↗ |
| Route | Subcutaneous | “subcutaneously dosed OM336” NCT07083960 ↗ |