Last reviewed 2026-04-20 · How we verify

Decholin (DEHYDROCHOLIC ACID)

Phase 2 active Small molecule Quality 21/100

Decholin (generic name: DEHYDROCHOLIC ACID) is a drug. It is currently in Phase 2 development for Constipation, Disorder of biliary tract, Incomplete passage of stool.

Decholin works by stimulating the contraction of the gallbladder and increasing bile flow.

Decholin, also known as Dehydrocholic acid, is a small molecule drug with unknown drug class and target. It is used to treat constipation, disorders of the biliary tract, and incomplete passage of stool. The commercial status of Decholin is unknown, but it is likely to be off-patent. Decholin's safety considerations are not well-documented, but it is essential to monitor patients for potential side effects. Further research is needed to fully understand Decholin's pharmacology and clinical applications.

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	DEHYDROCHOLIC ACID
Modality	Small molecule
Therapeutic area	Urology
Phase	Phase 2

Mechanism of action

Imagine your gallbladder as a water balloon that stores bile, a digestive fluid. Decholin helps to squeeze the balloon, releasing bile into the digestive system to aid in fat digestion and prevent constipation.

Approved indications

Constipation
Disorder of biliary tract
Incomplete passage of stool

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:

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

Frequently asked questions about Decholin

What is Decholin?

Decholin (DEHYDROCHOLIC ACID) is a Small molecule drug, indicated for Constipation, Disorder of biliary tract, Incomplete passage of stool.

How does Decholin work?

Decholin works by stimulating the contraction of the gallbladder and increasing bile flow.

What is Decholin used for?

Decholin is indicated for Constipation, Disorder of biliary tract, Incomplete passage of stool.

What is the generic name of Decholin?

DEHYDROCHOLIC ACID is the generic (nonproprietary) name of Decholin.

What development phase is Decholin in?

Decholin is in Phase 2.

Therapeutic area: All drugs in Urology
Indication: Drugs for Constipation
Indication: Drugs for Disorder of biliary tract
Indication: Drugs for Incomplete passage of stool

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