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Remaxol
Remaxol is a Small molecule drug developed by POLYSAN Scientific & Technological Pharmaceutical Company. It is currently in Phase 3 development. Also known as: inosine + meglumine + methionine + nicotinamide + succinic acid, Remaxol (succinate + methionine + inosine + nicotinamide).
Remaxol is a solution for infusions and enteric-coated tablets used in clinical trials for various liver conditions, including jaundice, cholestasis, and drug-induced liver injury. It has been studied in a multicenter, double-blind, placebo-controlled trial for malignant mechanical jaundice.
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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 | Remaxol |
|---|---|
| Also known as | inosine + meglumine + methionine + nicotinamide + succinic acid, Remaxol (succinate + methionine + inosine + nicotinamide) |
| Sponsor | POLYSAN Scientific & Technological Pharmaceutical Company |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
- Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis (PHASE2, PHASE3)
- Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
- Remaxol® in Mechanical Jaundice of Non-malignant Origin (PHASE3)
- Remaxol® in Malignant Mechanical Jaundice (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:
- Remaxol CI brief — competitive landscape report
- Remaxol updates RSS · CI watch RSS
- POLYSAN Scientific & Technological Pharmaceutical Company portfolio CI
Frequently asked questions about Remaxol
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Related
- Manufacturer: POLYSAN Scientific & Technological Pharmaceutical Company — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: inosine + meglumine + methionine + nicotinamide + succinic acid, Remaxol (succinate + methionine + inosine + nicotinamide)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing