Last reviewed 2026-06-02 · How we verify

Bilastin

Charite University, Berlin, Germany · Phase 3 active Small molecule ✓ Verified May 2026 Quality 4/100

Bilastin is a Small molecule drug developed by Charite University, Berlin, Germany. It is currently in Phase 3 development for Allergic rhinitis, Urticaria. Also known as: Bilaxten.

Bilastin is a small molecule that acts as an inverse agonist of the histamine H1 receptor. It is used to treat chronic urticaria, specifically in a condition known as chronic spontaneous urticaria.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Bilastin
Also known as	Bilaxten
Sponsor	Charite University, Berlin, Germany
Target	Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

Allergic rhinitis
Urticaria

Common side effects

No common side effects on file.

Key clinical trials

Bilastine Updosing in Chronic Spontaneous Urticaria (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:

Bilastin CI brief — competitive landscape report
Bilastin updates RSS · CI watch RSS
Charite University, Berlin, Germany portfolio CI

Frequently asked questions about Bilastin

What is Bilastin?

Bilastin is a Small molecule drug developed by Charite University, Berlin, Germany, indicated for Allergic rhinitis, Urticaria.

What is Bilastin used for?

Bilastin is indicated for Allergic rhinitis, Urticaria.

Who makes Bilastin?

Bilastin is developed by Charite University, Berlin, Germany (see full Charite University, Berlin, Germany pipeline at /company/charite-university-berlin-germany).

Is Bilastin also known as anything else?

Bilastin is also known as Bilaxten.

What development phase is Bilastin in?

Bilastin is in Phase 3.

What does Bilastin target?

Bilastin targets Histamine H1 receptor.

Target: All drugs targeting Histamine H1 receptor
Manufacturer: Charite University, Berlin, Germany — full pipeline
Therapeutic area: All drugs in Other
Indication: Drugs for Allergic rhinitis
Indication: Drugs for Urticaria
Also known as: Bilaxten

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