Last reviewed 2026-05-26 · How we verify

Zepelin (ACITAZANOLAST)

Phase 2 active Small molecule Under review

Zepelin (generic name: ACITAZANOLAST) is a acitazanolast drug. It is currently in Phase 2 development for Allergic conjunctivitis.

Acitazanolast works by blocking the action of mast cells, which are involved in the allergic response.

Zepelin is a small molecule with the synonyms ACITAZANOLAST and ACITAZANOLAST HYDRATE. It has been studied in a clinical trial (NCT02904837) for the treatment of Parkinson's Disease, where it was compared to control training.

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	ACITAZANOLAST
Drug class	acitazanolast
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of mast cells like the fire alarm in your body. When you're exposed to an allergen, like pollen, it triggers the mast cells to sound the alarm, releasing chemicals that cause inflammation and itching. Acitazanolast silences the fire alarm, reducing the allergic response and relieving symptoms.

Approved indications

Allergic conjunctivitis

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:

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

Frequently asked questions about Zepelin

What is Zepelin?

Zepelin (ACITAZANOLAST) is a acitazanolast drug, indicated for Allergic conjunctivitis.

How does Zepelin work?

Acitazanolast works by blocking the action of mast cells, which are involved in the allergic response.

What is Zepelin used for?

Zepelin is indicated for Allergic conjunctivitis.

What is the generic name of Zepelin?

ACITAZANOLAST is the generic (nonproprietary) name of Zepelin.

What drug class is Zepelin in?

Zepelin belongs to the acitazanolast class. See all acitazanolast drugs at /class/acitazanolast.

What development phase is Zepelin in?

Zepelin is in Phase 2.

Drug class: All acitazanolast drugs
Therapeutic area: All drugs in Other
Indication: Drugs for Allergic conjunctivitis

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