Last reviewed · How we verify
manidipine
manidipine is a Small molecule drug developed by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. It is currently in Phase 2 development.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | manidipine |
|---|---|
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Target | Voltage-gated L-type calcium channel, Cruzipain |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Exploration of Manidipine to Reverse Aortic Valve Calcification (PHASE2)
- Manidipine Versus Amlodipine in Patients With Hypertension (PHASE4)
- Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment (PHASE4)
- Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) (PHASE3)
- A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients (PHASE3)
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:
- manidipine CI brief — competitive landscape report
- manidipine updates RSS · CI watch RSS
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology portfolio CI
Frequently asked questions about manidipine
What is manidipine?
Who makes manidipine?
What development phase is manidipine in?
What does manidipine target?
Related
- Target: All drugs targeting Voltage-gated L-type calcium channel, Cruzipain
- Manufacturer: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — full pipeline
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing