Drugs / MH002
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07296315 | Apr 2026 → Sep 2027 expected | ulcerative colitis | MRM Health NV | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | MRM Health NV | Regulatory MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis mrmhealth.com ↗
MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis |
| 2026-01-09 | MRM Health NV | Regulatory MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis mrmhealth.com ↗
MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. |
| 2024-04-16 | MRM Health NV | Results MRM Health Reports Safety and Positive Efficacy Data in Pouchitis in Phase 2a Clinical Study with MH002 mrmhealth.com ↗
MRM Health NV, a clinical -stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases , today reports positive topline results from its Phase 2a clinical trial with MH002 in the orphan disease indication Pouchitis. |
| 2023-09-19 | MRM Health NV | Results MRM Health Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis mrmhealth.com ↗
MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC). |
| 2022-06-28 | MRM Health NV | Regulatory MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis mrmhealth.com ↗
MRM Health, a clinical-stage biopharmaceutical company developing next -generation live microbiome consortia therapeutics, announced today that they have received regulatory approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium to start a Phase 2 trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis. |
| 2021-09-28 | MRM Health NV | Regulatory MRM Health Receives CTA Approval for Phase 1b/2a Trial with Next Generation Optimized Consortium Therapeutic MH002 in Ulcerative Colitis mrmhealth.com ↗
MRM Health Receives CTA Approval for Phase 1b/2a Trial with Next Generation Optimized Consortium Therapeutic MH002 in Ulcerative Colitis |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MH002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07296315 ↗ |
| Action | Restore | “used to restore the normal function of a gut that is damaged by ulcerative colitis (UC).” NCT07296315 ↗ |
| Modality | Other / unclassified | “MH002 is a live biotherapeutic product (LBP).” NCT07296315 ↗ |
| Route | Oral | “administered orally (in a capsule) once daily” NCT07296315 ↗ |