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Comparator: ondansetron IV
Comparator: ondansetron IV is a 5-HT3 receptor antagonist Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of nausea and vomiting induced by chemotherapy, Prevention of postoperative nausea and vomiting, Prevention of radiation-induced nausea and vomiting.
Ondansetron is a selective 5-HT3 receptor antagonist that blocks serotonin signaling in the chemoreceptor trigger zone and gastrointestinal tract to prevent nausea and vomiting.
Ondansetron IV is a small molecule used as a comparator in clinical trials for conditions such as chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, and pruritus. It has been compared to other interventions, including fosaprepitant dimeglumine, aprepitant, and dexamethasone, in studies such as NCT00619359.
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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). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Comparator: ondansetron IV |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | 5-HT3 receptor antagonist |
| Target | 5-HT3 receptor |
| Modality | Small molecule |
| Therapeutic area | Supportive Care / Antiemetic |
| Phase | Phase 3 |
Mechanism of action
Ondansetron selectively antagonizes 5-hydroxytryptamine (serotonin) at the 5-HT3 receptor, which is located on vagal afferent nerves in the gastrointestinal tract and in the chemoreceptor trigger zone of the brain. By blocking these receptors, it prevents the transmission of emetic signals that would otherwise trigger the vomiting center, making it highly effective for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).
Approved indications
- Prevention of nausea and vomiting induced by chemotherapy
- Prevention of postoperative nausea and vomiting
- Prevention of radiation-induced nausea and vomiting
Common side effects
- Headache
- Constipation
- Diarrhea
- Fatigue
- Dizziness
Key clinical trials
- Phase I PK and Safety Study of Ondansetron Inhalation Powder (PHASE1)
- Comparison of Haloperidol and Ondansetron in Reducing Postoperative Nausea and Vomiting in RA-SAB Patients (NA)
- Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients? (PHASE4)
- Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy (PHASE2)
- Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy (PHASE2)
- The Effect of Intravenous Granisetron and Ondansetron in Patients Undergoing Cesarean Section (PHASE3)
- Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study (PHASE3)
- Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029) (PHASE2)
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:
- Comparator: ondansetron IV CI brief — competitive landscape report
- Comparator: ondansetron IV updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: ondansetron IV
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Related
- Drug class: All 5-HT3 receptor antagonist drugs
- Target: All drugs targeting 5-HT3 receptor
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Supportive Care / Antiemetic
- Indication: Drugs for Prevention of nausea and vomiting induced by chemotherapy
- Indication: Drugs for Prevention of postoperative nausea and vomiting
- Indication: Drugs for Prevention of radiation-induced nausea and vomiting
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing