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Granulokine
Granulokine is a Biologic drug developed by Megalabs. It is currently in Phase 3 development.
Granulokine is a substance being studied in clinical trials for various conditions, including breast cancer, infertility, and embryo development, often in comparison to filgrastim. It is also being compared to filgrastim in terms of pharmacokinetic and pharmacodynamic parameters in a clinical trial.
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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 | Granulokine |
|---|---|
| Sponsor | Megalabs |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers (PHASE1)
- Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy (PHASE3)
- Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A. (PHASE1)
- Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF (PHASE4)
- Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy (PHASE2)
- A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer (PHASE3)
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:
- Granulokine CI brief — competitive landscape report
- Granulokine updates RSS · CI watch RSS
- Megalabs portfolio CI
Frequently asked questions about Granulokine
What is Granulokine?
Who makes Granulokine?
What development phase is Granulokine in?
Related
- Manufacturer: Megalabs — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing