Last reviewed · How we verify
Clemizole HCl
Clemizole HCl is a H1-receptor antagonist (antihistamine) Small molecule drug developed by Epygenix. It is currently in Phase 3 development for Allergic conditions and pruritus (investigational in Phase 3). Also known as: EPX-100, Clemizole.
Clemizole HCl is a histamine H1-receptor antagonist that blocks histamine-mediated immune and inflammatory responses.
Clemizole HCl is a small molecule used in clinical trials for various conditions, including Dravet Syndrome, Hepatocellular Carcinoma, Lennox Gastaut Syndrome, and Hepatitis C. It has been studied in a 20-week multicenter trial as EPX-100 (Clemizole Hydrochloride) in participants with Dravet Syndrome.
-
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). -
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 | 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 | Clemizole HCl |
|---|---|
| Also known as | EPX-100, Clemizole |
| Sponsor | Epygenix |
| Drug class | H1-receptor antagonist (antihistamine) |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy / Inflammation |
| Phase | Phase 3 |
Mechanism of action
Clemizole is a first-generation antihistamine that crosses the blood-brain barrier and antagonizes H1 receptors on mast cells, basophils, and other immune cells. By blocking histamine signaling, it reduces allergic and inflammatory responses. The drug has also been investigated for potential immunomodulatory effects beyond classical antihistamine activity.
Approved indications
- Allergic conditions and pruritus (investigational in Phase 3)
Common side effects
- Drowsiness / sedation
- Dry mouth
- Dizziness
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:
- Clemizole HCl CI brief — competitive landscape report
- Clemizole HCl updates RSS · CI watch RSS
- Epygenix portfolio CI
Frequently asked questions about Clemizole HCl
What is Clemizole HCl?
How does Clemizole HCl work?
What is Clemizole HCl used for?
Who makes Clemizole HCl?
Is Clemizole HCl also known as anything else?
What drug class is Clemizole HCl in?
What development phase is Clemizole HCl in?
What are the side effects of Clemizole HCl?
What does Clemizole HCl target?
Related
- Drug class: All H1-receptor antagonist (antihistamine) drugs
- Target: All drugs targeting Histamine H1 receptor
- Manufacturer: Epygenix — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy / Inflammation
- Indication: Drugs for Allergic conditions and pruritus (investigational in Phase 3)
- Also known as: EPX-100, Clemizole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing