Drugs / MabionCD20
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04680962 | Aug 2023 | rheumatoid arthritis | Mabion SA | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-08-26 | Mabion SA | Regulatory MabionCD20 – FDA grants type B pre-IND meeting in just 14 days mabion.eu ↗
The U.S. FDA scheduled a Type B Pre -IND meeting (PIND 183961) for MabionCD20 within just 14 days of submission, setting the formal regulatory discussion for October 5, 2026 |
| 2023-02-08 | Mabion SA | Regulatory Mabion has received ODD status from the FDA for the drug MabionCD20 in the indication of autoimmune hemolytic anemia mabion.eu ↗
Mabion has received ODD status from the FDA for the drug MabionCD20 in the indication of autoimmune hemolytic anemia |
| 2023-01-27 | Mabion SA | Regulatory Mabion has secured approval from the FDA to designate MabionCD20 as an orphan drug for the indication of membranous nephropathy mabion.eu ↗
Mabion has secured approval from the FDA to designate MabionCD20 as an orphan drug for the indication of membranous nephropathy |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MabionCD20 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04680962 ↗ |
| Route | Intravenous | “Intravenous infusion, 10 mg/ml concentrate, 500 ml” NCT04680962 ↗ |