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Fendilin (FENDILINE)
Fendilin (generic name: FENDILINE) is a fendiline drug. It is currently in Phase 2 development for Ischemic heart disease.
Fendiline works by binding to the extracellular calcium-sensing receptor, which helps regulate calcium levels in the body.
Fendilin is a small molecule with the synonyms Fendilina, Fendiline, and Fendiline. It has been studied in relation to post-stroke pneumonia in a real-world retrospective cohort study, comparing its effects to angiotensin converting enzyme inhibitors, Calcium Channel Blockers, and Angiotensin Receptor Blockers.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | FENDILINE |
|---|---|
| Drug class | fendiline |
| Target | Extracellular calcium-sensing receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
Think of it like a thermostat in your home. The extracellular calcium-sensing receptor acts like a thermostat, helping to keep calcium levels in the body stable. Fendiline helps this thermostat work better, which can help treat conditions like ischemic heart disease.
Approved indications
- Ischemic heart disease
Common side effects
Key clinical trials
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:
- Fendilin CI brief — competitive landscape report
- Fendilin updates RSS · CI watch RSS
Frequently asked questions about Fendilin
What is Fendilin?
How does Fendilin work?
What is Fendilin used for?
What is the generic name of Fendilin?
What drug class is Fendilin in?
What development phase is Fendilin in?
What does Fendilin target?
Related
- Drug class: All fendiline drugs
- Target: All drugs targeting Extracellular calcium-sensing receptor
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Ischemic heart disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing