COMPANY
Meitheal Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Our biopharmaceutical products begin with discovery, move into research and development, pass through clinical trials when needed, continue into manufacturing, and finally achieve launch in the market. From company website Source · Oct 13, 2026
Timeline
- Trial start Phase 4: Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women source ↗
- FDA FDA Original approval: CONTEPO (fosfomycin disodium) — NDA212271, Oct 22, 2025. Applicant at approval: Meitheal Pharmaceuticals Inc. source ↗
Upcoming milestones
- 2027-09 (ESTIMATED) · Phase 4 · Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women · NCT07618299
Clinical trials (lead sponsor) 1
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07618299 | Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women | Phase 4 | Recruiting | Sep 22, 2026 | 2027-09 (estimated) |
FDA records (last 2 years)
- FDA Original approval: CONTEPO (fosfomycin disodium) — NDA212271, Oct 22, 2025. Applicant at approval: Meitheal Pharmaceuticals Inc. source ↗
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