Last reviewed · How we verify
Mycophenolatmofetil
Mycophenolatmofetil is a Small molecule drug developed by Hannover Medical School. It is currently in Phase 3 development. Also known as: Cellcept.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Mycophenolatmofetil |
|---|---|
| Also known as | Cellcept |
| Sponsor | Hannover Medical School |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation (PHASE3)
- MMF After Pediatric Liver Transplantation (NA)
- MMF and Calcineurin Inhibitor Withdrawal in CAN (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mycophenolatmofetil CI brief — competitive landscape report
- Mycophenolatmofetil updates RSS · CI watch RSS
- Hannover Medical School portfolio CI
Frequently asked questions about Mycophenolatmofetil
What is Mycophenolatmofetil?
Who makes Mycophenolatmofetil?
Is Mycophenolatmofetil also known as anything else?
What development phase is Mycophenolatmofetil in?
Related
- Manufacturer: Hannover Medical School — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Cellcept
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing