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Granisetron Injection
Granisetron Injection is a 5-HT3 receptor antagonist Small molecule drug developed by Eye & ENT Hospital of Fudan University. It is currently in Phase 3 development for Prevention of nausea and vomiting induced by chemotherapy, Prevention of post-operative nausea and vomiting, Prevention of radiation-induced nausea and vomiting. Also known as: granisetron.
Granisetron blocks serotonin 5-HT3 receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting.
Granisetron blocks serotonin 5-HT3 receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting. Used for Prevention of nausea and vomiting induced by chemotherapy, Prevention of post-operative nausea and vomiting, Prevention of radiation-induced nausea and vomiting.
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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 | Granisetron Injection |
|---|---|
| Also known as | granisetron |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Drug class | 5-HT3 receptor antagonist |
| Target | 5-HT3 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Granisetron is a selective antagonist of serotonin 5-HT3 receptors, which are located on chemoreceptor trigger zone neurons and on the vagal afferent nerves of the gastrointestinal tract. By blocking these receptors, it prevents the transmission of emetic signals to the vomiting center in the brain, thereby suppressing nausea and vomiting induced by chemotherapy, radiation, or post-operative conditions.
Approved indications
- Prevention of nausea and vomiting induced by chemotherapy
- Prevention of post-operative nausea and vomiting
- Prevention of radiation-induced nausea and vomiting
Common side effects
- Headache
- Constipation
- Asthenia/fatigue
- Diarrhea
- Abdominal pain
- Fever
Key clinical trials
- Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders (PHASE4)
- Staccato® Granisetron Single Dose PK (PHASE1)
- Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS) (PHASE1)
- PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron (PHASE1)
- Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy (PHASE2)
- Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy (NA)
- Clonidine Versus Granisetron for Shivering Prevension (PHASE2)
- The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy (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:
- Granisetron Injection CI brief — competitive landscape report
- Granisetron Injection updates RSS · CI watch RSS
- Eye & ENT Hospital of Fudan University portfolio CI
Frequently asked questions about Granisetron Injection
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Related
- Drug class: All 5-HT3 receptor antagonist drugs
- Target: All drugs targeting 5-HT3 receptor
- Manufacturer: Eye & ENT Hospital of Fudan University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Prevention of nausea and vomiting induced by chemotherapy
- Indication: Drugs for Prevention of post-operative nausea and vomiting
- Indication: Drugs for Prevention of radiation-induced nausea and vomiting
- Also known as: granisetron