Last reviewed 2026-05-27 · How we verify

(+/-)-Trimebutine (TRIMEBUTINE)

Phase 3 active Small molecule ✓ Verified May 2026 Quality 32/100

(+/-)-Trimebutine (generic name: TRIMEBUTINE) is a trimebutine drug. It is currently in Phase 3 development.

Trimebutine works by blocking certain receptors in the gut to reduce spasms and inflammation.

(+/-)-Trimebutine is a small molecule with the synonyms TRIMEBUTINA, TRIMEBUTINE, TRIMEBUTINE, and TRIMEBUTINE.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	TRIMEBUTINE
Drug class	trimebutine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 3

Mechanism of action

Imagine your gut is like a muscle that can get crampy and inflamed. Trimebutine helps by blocking the signals that tell the muscle to contract and get inflamed, which can help with symptoms like cramps and diarrhea.

Approved indications

No approved indications tracked.

Common side effects

Hyponatraemia
Necrosis ischaemic
Coma
Acute kidney injury
Beta haemolytic streptococcal infection
Pneumonia streptococcal
Colitis
Poisoning deliberate
Rash maculo-papular
Febrile bone marrow aplasia
Drug reaction with eosinophilia and systemic symptoms
Anal fissure

Key clinical trials

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:

(+/-)-Trimebutine CI brief — competitive landscape report
(+/-)-Trimebutine updates RSS · CI watch RSS

Frequently asked questions about (+/-)-Trimebutine

What is (+/-)-Trimebutine?

(+/-)-Trimebutine (TRIMEBUTINE) is a trimebutine drug.

How does (+/-)-Trimebutine work?

Trimebutine works by blocking certain receptors in the gut to reduce spasms and inflammation.

What is the generic name of (+/-)-Trimebutine?

TRIMEBUTINE is the generic (nonproprietary) name of (+/-)-Trimebutine.

What drug class is (+/-)-Trimebutine in?

(+/-)-Trimebutine belongs to the trimebutine class. See all trimebutine drugs at /class/trimebutine.

What development phase is (+/-)-Trimebutine in?

(+/-)-Trimebutine is in Phase 3.

What are the side effects of (+/-)-Trimebutine?

Common side effects of (+/-)-Trimebutine include Hyponatraemia, Necrosis ischaemic, Coma, Acute kidney injury, Beta haemolytic streptococcal infection, Pneumonia streptococcal.

Drug class: All trimebutine drugs
Therapeutic area: All drugs in Neuroscience

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