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Sibelium
Sibelium is a Small molecule drug developed by Ruijin Hospital. It is currently in Phase 1 development.
Sibelium, also known as flunarizine, is a small molecule drug classified as a calcium antagonist. It is used for various indications, including those related to migraine, but its specific uses are not detailed in the provided information.
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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 | Sibelium |
|---|---|
| Sponsor | Ruijin Hospital |
| Target | Adenosine receptor A3, CAAX prenyl protease 2, 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Sedation
- Fatique
- paresthesia
- memory difficulties
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
- Ruijin Hospital portfolio CI
Frequently asked questions about Sibelium
What is Sibelium?
Who makes Sibelium?
What development phase is Sibelium in?
What are the side effects of Sibelium?
What does Sibelium target?
Related
- Target: All drugs targeting Adenosine receptor A3, CAAX prenyl protease 2, 5-hydroxytryptamine receptor 1A
- Manufacturer: Ruijin Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing