Last reviewed 2026-04-20 · How we verify

Biogastrone (CARBENOXOLONE)

Phase 2 active Small molecule

Biogastrone (generic name: CARBENOXOLONE) is a carbenoxolone drug. It is currently in Phase 2 development for Peptic ulcer, Ulcer of esophagus.

Biogastrone works by inhibiting the enzyme that converts cortisol into a more potent form, reducing inflammation in the stomach and esophagus.

Biogastrone, also known as carbenoxolone, is a small molecule drug that targets corticosteroid 11-beta-dehydrogenase isozyme 1. It is used to treat peptic ulcers and ulcers of the esophagus. The commercial status of Biogastrone is unclear, as it is not known whether it is patented or generic, off-patent or not. Key safety considerations are not well-documented. It is not FDA-approved.

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	CARBENOXOLONE
Drug class	carbenoxolone
Target	Corticosteroid 11-beta-dehydrogenase isozyme 1
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 2

Mechanism of action

Think of it like a fire alarm in a building. Cortisol is like a fire that can get out of control and cause damage. Biogastrone is like a fire alarm that sounds when cortisol gets too strong, helping to prevent damage to the stomach and esophagus.

Approved indications

Peptic ulcer
Ulcer of esophagus

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Biogastrone CI brief — competitive landscape report
Biogastrone updates RSS · CI watch RSS

Frequently asked questions about Biogastrone

What is Biogastrone?

Biogastrone (CARBENOXOLONE) is a carbenoxolone drug, indicated for Peptic ulcer, Ulcer of esophagus.

How does Biogastrone work?

Biogastrone works by inhibiting the enzyme that converts cortisol into a more potent form, reducing inflammation in the stomach and esophagus.

What is Biogastrone used for?

Biogastrone is indicated for Peptic ulcer, Ulcer of esophagus.

What is the generic name of Biogastrone?

CARBENOXOLONE is the generic (nonproprietary) name of Biogastrone.

What drug class is Biogastrone in?

Biogastrone belongs to the carbenoxolone class. See all carbenoxolone drugs at /class/carbenoxolone.

What development phase is Biogastrone in?

Biogastrone is in Phase 2.

What does Biogastrone target?

Biogastrone targets Corticosteroid 11-beta-dehydrogenase isozyme 1 and is a carbenoxolone.

Drug class: All carbenoxolone drugs
Target: All drugs targeting Corticosteroid 11-beta-dehydrogenase isozyme 1
Therapeutic area: All drugs in Gastroenterology
Indication: Drugs for Peptic ulcer
Indication: Drugs for Ulcer of esophagus

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