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Granisetron IV
Granisetron IV is a Small molecule drug developed by Kyowa Kirin Pharmaceutical Development Ltd. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 IV |
|---|---|
| Sponsor | Kyowa Kirin Pharmaceutical Development Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Fatigue
- Constipation
- Diarrhoea
- Decreased appetite
- Neutrophil count decreased
- Nausea
- Headache
- White blood cell count decreased
- Neutropenia
- Paraesthesia
- Dizziness
- Alopecia
Key clinical trials
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1, PHASE2)
- APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (PHASE3)
- A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC (PHASE3)
- A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
- Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (PHASE4)
- Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections (PHASE4)
- Cisplatin Disposition and Kidney Injury (PHASE3)
- A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery (PHASE4)
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 IV CI brief — competitive landscape report
- Granisetron IV updates RSS · CI watch RSS
- Kyowa Kirin Pharmaceutical Development Ltd portfolio CI
Frequently asked questions about Granisetron IV
What is Granisetron IV?
Who makes Granisetron IV?
What development phase is Granisetron IV in?
What are the side effects of Granisetron IV?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing