Last reviewed · How we verify
Sibelium (FLUNARIZINE)
Sibelium (generic name: FLUNARIZINE) is a flunarizine drug. It is currently in Phase 2 development.
Flunarizine works by binding to the Sigma non-opioid intracellular receptor 1, which is involved in various cellular processes.
Sibelium, also known as Flunarizine, is a small molecule medication used to treat various conditions, including migraine and adolescent migraine. It is typically administered in a dosage of 5mg.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | FLUNARIZINE |
|---|---|
| Drug class | flunarizine |
| Target | Adenosine receptor A3, CAAX prenyl protease 2, 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Mechanism of action
Imagine your cells have locks on them, and Flunarizine has a key that fits into one of those locks. When it binds to the receptor, it can affect how the cell behaves and responds to its environment. This can lead to changes in how the cell functions and interacts with other cells.
Approved indications
Common side effects
- Bronchial hyperreactivity
- Breast disorder
- Withdrawal syndrome
- Drug intolerance
- Therapy partial responder
- Paraesthesia
Key clinical trials
- An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers (PHASE1)
- ACT Therapy for HF Migraine (NA)
- Comparative Efficacy of Flunarizine and Propanolol in Pediatric Migraine (NA)
- Chinese Real-world Study of Treatment of Vestibular Migraine
- Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura (PHASE1)
- Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG (NA)
- Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine
- Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care (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:
- Sibelium CI brief — competitive landscape report
- Sibelium updates RSS · CI watch RSS
Frequently asked questions about Sibelium
What is Sibelium?
How does Sibelium work?
What is the generic name of Sibelium?
What drug class is Sibelium in?
What development phase is Sibelium in?
What are the side effects of Sibelium?
What does Sibelium target?
Related
- Drug class: All flunarizine drugs
- Target: All drugs targeting Adenosine receptor A3, CAAX prenyl protease 2, 5-hydroxytryptamine receptor 1A
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing