Last reviewed 2026-04-23 · How we verify

Clemastine IV

Erasmus Medical Center · Phase 2 active Small molecule

Clemastine IV is a Antihistamine Small molecule drug developed by Erasmus Medical Center. It is currently in Phase 2 development for Allergic rhinitis, Urticaria.

Histamine H1 receptor antagonist

Histamine H1 receptor antagonist Used for Allergic rhinitis, Urticaria.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Clemastine IV
Sponsor	Erasmus Medical Center
Drug class	Antihistamine
Target	Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Allergy
Phase	Phase 2

Mechanism of action

Clemastine works by blocking the action of histamine at H1 receptors, which are involved in allergic responses.

Approved indications

Allergic rhinitis
Urticaria

Common side effects

Drowsiness
Dry mouth
Headache

Key clinical trials

The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment

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:

Clemastine IV CI brief — competitive landscape report
Clemastine IV updates RSS · CI watch RSS
Erasmus Medical Center portfolio CI

Frequently asked questions about Clemastine IV

What is Clemastine IV?

Clemastine IV is a Antihistamine drug developed by Erasmus Medical Center, indicated for Allergic rhinitis, Urticaria.

How does Clemastine IV work?

Histamine H1 receptor antagonist

What is Clemastine IV used for?

Clemastine IV is indicated for Allergic rhinitis, Urticaria.

Who makes Clemastine IV?

Clemastine IV is developed by Erasmus Medical Center (see full Erasmus Medical Center pipeline at /company/erasmus-medical-center).

What drug class is Clemastine IV in?

Clemastine IV belongs to the Antihistamine class. See all Antihistamine drugs at /class/antihistamine.

What development phase is Clemastine IV in?

Clemastine IV is in Phase 2.

What are the side effects of Clemastine IV?

Common side effects of Clemastine IV include Drowsiness, Dry mouth, Headache.

What does Clemastine IV target?

Clemastine IV targets Histamine H1 receptor and is a Antihistamine.

Drug class: All Antihistamine drugs
Target: All drugs targeting Histamine H1 receptor
Manufacturer: Erasmus Medical Center — full pipeline
Therapeutic area: All drugs in Allergy
Indication: Drugs for Allergic rhinitis
Indication: Drugs for Urticaria

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing