Last reviewed 2026-05-19 · How we verify

Ulimorelin Intravenously (IV)

Tranzyme, Inc. · Phase 3 active Small molecule Under review

Ulimorelin Intravenously (IV) is a Ghrelin receptor agonist Small molecule drug developed by Tranzyme, Inc.. It is currently in Phase 3 development for Symptomatic gastroesophageal reflux disease (GERD) in patients with type 1 diabetes mellitus, Symptomatic diabetic gastroparesis.

Ulimorelin is a ghrelin receptor agonist that stimulates gastric emptying.

Ulimorelin is a small molecule administered intravenously, studied for its efficacy and safety in treating gastrointestinal dysmotility. It is being investigated in a clinical trial, ULISES 008, as a potential treatment for this condition.

Likelihood of approval

58.3% 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).

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	Ulimorelin Intravenously (IV)
Sponsor	Tranzyme, Inc.
Drug class	Ghrelin receptor agonist
Target	Ghrelin receptor
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 3

Mechanism of action

Ulimorelin works by mimicking the action of ghrelin, a natural hormone that helps regulate gastric emptying. This leads to faster movement of food from the stomach to the small intestine, which can help alleviate symptoms of gastroparesis.

Approved indications

Symptomatic gastroesophageal reflux disease (GERD) in patients with type 1 diabetes mellitus
Symptomatic diabetic gastroparesis

Common side effects

Nausea
Vomiting
Abdominal pain

Key clinical trials

Ulimorelin Study of Efficacy and Safety (ULISES 008) (PHASE3)
Ulimorelin Study of Efficacy and Safety (ULISES 007) (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:

Ulimorelin Intravenously (IV) CI brief — competitive landscape report
Ulimorelin Intravenously (IV) updates RSS · CI watch RSS
Tranzyme, Inc. portfolio CI

Frequently asked questions about Ulimorelin Intravenously (IV)

What is Ulimorelin Intravenously (IV)?

Ulimorelin Intravenously (IV) is a Ghrelin receptor agonist drug developed by Tranzyme, Inc., indicated for Symptomatic gastroesophageal reflux disease (GERD) in patients with type 1 diabetes mellitus, Symptomatic diabetic gastroparesis.

How does Ulimorelin Intravenously (IV) work?

Ulimorelin is a ghrelin receptor agonist that stimulates gastric emptying.

What is Ulimorelin Intravenously (IV) used for?

Ulimorelin Intravenously (IV) is indicated for Symptomatic gastroesophageal reflux disease (GERD) in patients with type 1 diabetes mellitus, Symptomatic diabetic gastroparesis.

Who makes Ulimorelin Intravenously (IV)?

Ulimorelin Intravenously (IV) is developed by Tranzyme, Inc. (see full Tranzyme, Inc. pipeline at /company/tranzyme-inc).

What drug class is Ulimorelin Intravenously (IV) in?

Ulimorelin Intravenously (IV) belongs to the Ghrelin receptor agonist class. See all Ghrelin receptor agonist drugs at /class/ghrelin-receptor-agonist.

What development phase is Ulimorelin Intravenously (IV) in?

Ulimorelin Intravenously (IV) is in Phase 3.

What are the side effects of Ulimorelin Intravenously (IV)?

Common side effects of Ulimorelin Intravenously (IV) include Nausea, Vomiting, Abdominal pain.

What does Ulimorelin Intravenously (IV) target?

Ulimorelin Intravenously (IV) targets Ghrelin receptor and is a Ghrelin receptor agonist.

Drug class: All Ghrelin receptor agonist drugs
Target: All drugs targeting Ghrelin receptor
Manufacturer: Tranzyme, Inc. — full pipeline
Therapeutic area: All drugs in Gastroenterology
Indication: Drugs for Symptomatic gastroesophageal reflux disease (GERD) in patients with type 1 diabetes mellitus
Indication: Drugs for Symptomatic diabetic gastroparesis

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