Last reviewed 2026-05-22 · How we verify

Calmeran (AZACYCLONOL)

Phase 2 active Small molecule ✓ Verified May 2026

Calmeran (generic name: AZACYCLONOL) is a azacyclonol drug. It is currently in Phase 2 development.

Calmeran works by blocking the histamine H1 receptor, which helps to reduce allergic responses and other physiological effects caused by histamine.

Calmeran is a small molecule with synonyms including Ataractan, AZACICLONOL, and Frenoton.

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	AZACYCLONOL
Drug class	azacyclonol
Target	Histamine H1 receptor, Sodium channel alpha subunits; brain (Types I, II, III)
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a 'volume control' for histamine, a chemical that can cause allergic reactions and other issues. Calmeran acts like a 'mute button' for this volume control, reducing the effects of histamine and helping to alleviate symptoms. This can be especially helpful for people with allergies or other conditions where histamine plays a role.

Approved indications

No approved indications tracked.

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:

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

Frequently asked questions about Calmeran

What is Calmeran?

Calmeran (AZACYCLONOL) is a azacyclonol drug.

How does Calmeran work?

Calmeran works by blocking the histamine H1 receptor, which helps to reduce allergic responses and other physiological effects caused by histamine.

What is the generic name of Calmeran?

AZACYCLONOL is the generic (nonproprietary) name of Calmeran.

What drug class is Calmeran in?

Calmeran belongs to the azacyclonol class. See all azacyclonol drugs at /class/azacyclonol.

What development phase is Calmeran in?

Calmeran is in Phase 2.

What does Calmeran target?

Calmeran targets Histamine H1 receptor, Sodium channel alpha subunits; brain (Types I, II, III) and is a azacyclonol.

Drug class: All azacyclonol drugs
Target: All drugs targeting Histamine H1 receptor, Sodium channel alpha subunits; brain (Types I, II, III)
Therapeutic area: All drugs in Other

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