Last reviewed 2026-05-21 · How we verify

Rebamide

Chonnam National University Hospital · Phase 1 active Small molecule ✓ Verified May 2026

Rebamide is a Small molecule drug developed by Chonnam National University Hospital. It is currently in Phase 1 development. Also known as: Mucosta® (Korea Otsuka Pharmaceuticals Co.).

Rebamide is a medication used to study therapeutic equivalency and pharmacogenetics in clinical trials. It is being evaluated for bioequivalence in Korean volunteers in a study to compare the effects of two different preparations of rebamipide after a single oral dose.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Rebamide
Also known as	Mucosta® (Korea Otsuka Pharmaceuticals Co.)
Sponsor	Chonnam National University Hospital
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Bioequivalence of Rebamipide in Korean (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:

Rebamide CI brief — competitive landscape report
Rebamide updates RSS · CI watch RSS
Chonnam National University Hospital portfolio CI

Frequently asked questions about Rebamide

What is Rebamide?

Rebamide is a Small molecule drug developed by Chonnam National University Hospital.

Who makes Rebamide?

Rebamide is developed by Chonnam National University Hospital (see full Chonnam National University Hospital pipeline at /company/chonnam-national-university-hospital).

Is Rebamide also known as anything else?

Rebamide is also known as Mucosta® (Korea Otsuka Pharmaceuticals Co.).

What development phase is Rebamide in?

Rebamide is in Phase 1.

Manufacturer: Chonnam National University Hospital — full pipeline
Therapeutic area: All drugs in Other
Also known as: Mucosta® (Korea Otsuka Pharmaceuticals Co.)

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