Last reviewed 2026-05-21 · How we verify

Rupatadin

Marcus Maurer · Phase 2 active Small molecule ✓ Verified May 2026

Rupatadin is a Small molecule drug developed by Marcus Maurer. It is currently in Phase 2 development for Allergic rhinitis, Urticaria. Also known as: Each tablet contains 10 mg RUP.

Rupatadin is a small molecule that acts as a platelet-activating factor receptor antagonist. It has been studied for the treatment of mastocytosis and chronic urticaria in clinical trials.

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	Rupatadin
Also known as	Each tablet contains 10 mg RUP
Sponsor	Marcus Maurer
Target	Platelet-activating factor receptor, Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Approved indications

Allergic rhinitis
Urticaria

Common side effects

No common side effects on file.

Key clinical trials

Chronic Urticaria - Long Term Assessment of Effects of Rupatadine (PHASE3)
Study on Mastocytosis for Rupatadine Treatment (PHASE2, PHASE3)

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:

Rupatadin CI brief — competitive landscape report
Rupatadin updates RSS · CI watch RSS
Marcus Maurer portfolio CI

Frequently asked questions about Rupatadin

What is Rupatadin?

Rupatadin is a Small molecule drug developed by Marcus Maurer, indicated for Allergic rhinitis, Urticaria.

What is Rupatadin used for?

Rupatadin is indicated for Allergic rhinitis, Urticaria.

Who makes Rupatadin?

Rupatadin is developed by Marcus Maurer (see full Marcus Maurer pipeline at /company/marcus-maurer).

Is Rupatadin also known as anything else?

Rupatadin is also known as Each tablet contains 10 mg RUP.

What development phase is Rupatadin in?

Rupatadin is in Phase 2.

What does Rupatadin target?

Rupatadin targets Platelet-activating factor receptor, Histamine H1 receptor.

Target: All drugs targeting Platelet-activating factor receptor, Histamine H1 receptor
Manufacturer: Marcus Maurer — full pipeline
Therapeutic area: All drugs in Hematology
Indication: Drugs for Allergic rhinitis
Indication: Drugs for Urticaria
Also known as: Each tablet contains 10 mg RUP

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