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Standard: Ondansetron
Standard: Ondansetron is a Serotonin 5-HT3 receptor antagonist Small molecule drug developed by CCTU. It is currently in Phase 3 development for Prevention of nausea and vomiting caused by cancer chemotherapy, Prevention of nausea and vomiting caused by radiation therapy.
Ondansetron works by blocking serotonin receptors in the body, which helps to reduce nausea and vomiting.
Ondansetron is a small molecule antiemetic used to treat postoperative nausea and vomiting. It has been studied in various clinical trials for its effectiveness in managing postoperative symptoms.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Standard: Ondansetron |
|---|---|
| Sponsor | CCTU |
| Drug class | Serotonin 5-HT3 receptor antagonist |
| Target | 5-HT3 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ondansetron specifically targets the 5-HT3 receptor, a subtype of serotonin receptor found in the gastrointestinal tract and the central nervous system. By blocking these receptors, ondansetron reduces the vomiting reflex and alleviates nausea.
Approved indications
- Prevention of nausea and vomiting caused by cancer chemotherapy
- Prevention of nausea and vomiting caused by radiation therapy
Common side effects
- Headache
- Dizziness
- Constipation
- Diarrhea
- Fatigue
Key clinical trials
- Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults (NA)
- The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities (PHASE2)
- Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile (PHASE2)
- QIPB in Inguinal Hernia (NA)
- Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients (PHASE2)
- Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix (PHASE3)
- Psychosocial Factors and Postoperative Pain in Aesthetic Breast Surgery
- Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy (NA)
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:
- Standard: Ondansetron CI brief — competitive landscape report
- Standard: Ondansetron updates RSS · CI watch RSS
- CCTU portfolio CI
Frequently asked questions about Standard: Ondansetron
What is Standard: Ondansetron?
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What is Standard: Ondansetron used for?
Who makes Standard: Ondansetron?
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Related
- Drug class: All Serotonin 5-HT3 receptor antagonist drugs
- Target: All drugs targeting 5-HT3 receptor
- Manufacturer: CCTU — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Prevention of nausea and vomiting caused by cancer chemotherapy
- Indication: Drugs for Prevention of nausea and vomiting caused by radiation therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing