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Lergopenin (CLEMIZOLE)
Lergopenin (generic name: CLEMIZOLE) is a clemizole drug. It is currently in Phase 2 development.
Clemizole works by binding to the histamine H4 receptor, which is involved in the regulation of immune responses and inflammation.
Lergopenin is a small molecule with the synonyms AL-20 FREE BASE, CLEMIZOL, CLEMIZOLE, CLEMIZOLE, and NSC-46261.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | CLEMIZOLE |
|---|---|
| Drug class | clemizole |
| Target | Short transient receptor potential channel 4, Histamine H4 receptor, Short transient receptor potential channel 3 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Imagine your immune system is like a fire alarm that goes off when it detects something wrong. The histamine H4 receptor is like a switch that helps turn on the alarm. Clemizole blocks this switch, which can help reduce inflammation and other symptoms associated with immune system overactivity.
Approved indications
Common side effects
Key clinical trials
- An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome (PHASE3)
- A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome (PHASE3)
- Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects. (PHASE1)
- Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive (PHASE1)
- Clemizole HCl for Subjects With Hepatocellular Carcinoma (PHASE2)
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:
- Lergopenin CI brief — competitive landscape report
- Lergopenin updates RSS · CI watch RSS
Frequently asked questions about Lergopenin
What is Lergopenin?
How does Lergopenin work?
What is the generic name of Lergopenin?
What drug class is Lergopenin in?
What development phase is Lergopenin in?
What does Lergopenin target?
Related
- Drug class: All clemizole drugs
- Target: All drugs targeting Short transient receptor potential channel 4, Histamine H4 receptor, Short transient receptor potential channel 3
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing