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Mevalotin
Mevalotin is a Small molecule drug developed by Daiichi Sankyo. It is currently in Phase 2 development.
Mevalotin is not mentioned in the provided facts, but based on the information about pravastatin, it is a statin medication used for preventing cardiovascular disease in those at high risk and treating abnormal lipids. It is typically taken by mouth in combination with diet changes, exercise, and weight loss.
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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 | Mevalotin |
|---|---|
| Sponsor | Daiichi Sankyo |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Novel Treatment of Radiation Associated Dysphagia With Statins (PHASE2)
- Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial) (PHASE2)
- Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE) (PHASE2)
- Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma (PHASE3)
- Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions (PHASE1, PHASE2)
- Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) (PHASE2)
- Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy (PHASE1, PHASE2)
- IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease (PHASE1)
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:
- Mevalotin CI brief — competitive landscape report
- Mevalotin updates RSS · CI watch RSS
- Daiichi Sankyo portfolio CI
Frequently asked questions about Mevalotin
What is Mevalotin?
Who makes Mevalotin?
What development phase is Mevalotin in?
Related
- Manufacturer: Daiichi Sankyo — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing