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Ulimorelin Invtravenously (IV)
Ulimorelin Invtravenously (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 2 diabetes mellitus.
Ulimorelin is a ghrelin receptor agonist that stimulates gastric emptying.
Ulimorelin is a small molecule administered intravenously (IV) for the treatment of gastrointestinal dysmotility. It is a synthetic compound that has been studied in clinical trials, including the ULISES 008 study, to evaluate its efficacy and safety.
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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).
| 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 Invtravenously (IV) |
|---|---|
| Sponsor | Tranzyme, Inc. |
| Drug class | Ghrelin receptor agonist |
| Target | Ghrelin receptor |
| Modality | Small molecule |
| Therapeutic area | Gastrointestinal |
| Phase | Phase 3 |
Mechanism of action
Ulimorelin works by activating the ghrelin receptor, which is involved in regulating gastric motility and emptying. This leads to an increase in gastric emptying, which can help alleviate symptoms of gastroparesis.
Approved indications
- Symptomatic gastroesophageal reflux disease (GERD) in patients with type 2 diabetes mellitus
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
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:
- Ulimorelin Invtravenously (IV) CI brief — competitive landscape report
- Ulimorelin Invtravenously (IV) updates RSS · CI watch RSS
- Tranzyme, Inc. portfolio CI
Frequently asked questions about Ulimorelin Invtravenously (IV)
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Related
- Drug class: All Ghrelin receptor agonist drugs
- Target: All drugs targeting Ghrelin receptor
- Manufacturer: Tranzyme, Inc. — full pipeline
- Therapeutic area: All drugs in Gastrointestinal
- Indication: Drugs for Symptomatic gastroesophageal reflux disease (GERD) in patients with type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing