Last reviewed 2026-05-30 · How we verify

Remaxa, enteric-coated tablets

POLYSAN Scientific & Technological Pharmaceutical Company · Phase 2 active Small molecule ✓ Verified May 2026

Remaxa, enteric-coated tablets is a Small molecule drug developed by POLYSAN Scientific & Technological Pharmaceutical Company. It is currently in Phase 2 development. Also known as: inosine, methionine, nicotinamide, succinic acid.

Remaxa is an enteric-coated tablet, classified as a small molecule with an unknown mechanism of action. It is being studied in clinical trials for the treatment of intrahepatic cholestasis.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Remaxa, enteric-coated tablets
Also known as	inosine, methionine, nicotinamide, succinic acid
Sponsor	POLYSAN Scientific & Technological Pharmaceutical Company
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis (PHASE2, 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:

Remaxa, enteric-coated tablets CI brief — competitive landscape report
Remaxa, enteric-coated tablets updates RSS · CI watch RSS
POLYSAN Scientific & Technological Pharmaceutical Company portfolio CI

Frequently asked questions about Remaxa, enteric-coated tablets

What is Remaxa, enteric-coated tablets?

Remaxa, enteric-coated tablets is a Small molecule drug developed by POLYSAN Scientific & Technological Pharmaceutical Company.

Who makes Remaxa, enteric-coated tablets?

Remaxa, enteric-coated tablets is developed by POLYSAN Scientific & Technological Pharmaceutical Company (see full POLYSAN Scientific & Technological Pharmaceutical Company pipeline at /company/polysan-scientific-technological-pharmaceutical-company).

Is Remaxa, enteric-coated tablets also known as anything else?

Remaxa, enteric-coated tablets is also known as inosine, methionine, nicotinamide, succinic acid.

What development phase is Remaxa, enteric-coated tablets in?

Remaxa, enteric-coated tablets is in Phase 2.

Manufacturer: POLYSAN Scientific & Technological Pharmaceutical Company — full pipeline
Also known as: inosine, methionine, nicotinamide, succinic acid

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing