Last reviewed 2026-04-20 · How we verify

Bamipin (BAMIPINE)

Phase 2 active Small molecule Quality 28/100

Bamipin (generic name: BAMIPINE) is a bamipine drug. It is currently in Phase 2 development for Urticaria.

Bamipine blocks histamine at the H1 receptor to treat urticaria.

Bamipine (BAMIPINE) is a small molecule drug that targets the histamine H1 receptor. It is used to treat urticaria, a condition characterized by itchy hives. The commercial status of bamipine is currently unknown, and it is not clear if it is patented or available as a generic medication. Bamipine works by blocking the action of histamine at the H1 receptor, which helps to reduce the symptoms of urticaria. Further information on its pharmacokinetics and safety profile is needed.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	BAMIPINE
Drug class	bamipine
Target	Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's immune system is sending out a distress signal, releasing histamine to fight off an allergen. This histamine causes blood vessels to swell and leads to itchy hives. Bamipine acts like a key that locks onto the histamine, preventing it from binding to the H1 receptor and reducing the symptoms of urticaria.

Approved indications

Urticaria

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Bamipin CI brief — competitive landscape report
Bamipin updates RSS · CI watch RSS

Frequently asked questions about Bamipin

What is Bamipin?

Bamipin (BAMIPINE) is a bamipine drug, indicated for Urticaria.

How does Bamipin work?

Bamipine blocks histamine at the H1 receptor to treat urticaria.

What is Bamipin used for?

Bamipin is indicated for Urticaria.

What is the generic name of Bamipin?

BAMIPINE is the generic (nonproprietary) name of Bamipin.

What drug class is Bamipin in?

Bamipin belongs to the bamipine class. See all bamipine drugs at /class/bamipine.

What development phase is Bamipin in?

Bamipin is in Phase 2.

What does Bamipin target?

Bamipin targets Histamine H1 receptor and is a bamipine.

Drug class: All bamipine drugs
Target: All drugs targeting Histamine H1 receptor
Therapeutic area: All drugs in Immunology
Indication: Drugs for Urticaria

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