Last reviewed 2026-06-01 · How we verify

BETAMETHASONE ACIBUTATE

Phase 2 active Small molecule ✓ Verified Jun 2026

BETAMETHASONE ACIBUTATE is a Corticosteroid drug. It is currently in Phase 2 development.

BETAMETHASONE ACIBUTATE works by inhibiting the production of inflammatory mediators.

BETAMETHASONE ACIBUTATE is a small molecule medication. It is also known by the synonyms ACIBUTATE DE BETAMETHASONE, ACIBUTATO DE BETAMETASONA, and BETAMETHASONE ACIBUTATE.

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	BETAMETHASONE ACIBUTATE
Drug class	Corticosteroid
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's immune system as a fire alarm that goes off when it senses something wrong. BETAMETHASONE ACIBUTATE helps to turn down the volume on the fire alarm, reducing the amount of inflammation and immune response. This allows the body to heal and recover from conditions such as asthma or skin allergies.

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:

BETAMETHASONE ACIBUTATE CI brief — competitive landscape report
BETAMETHASONE ACIBUTATE updates RSS · CI watch RSS

Frequently asked questions about BETAMETHASONE ACIBUTATE

What is BETAMETHASONE ACIBUTATE?

BETAMETHASONE ACIBUTATE is a Corticosteroid drug.

How does BETAMETHASONE ACIBUTATE work?

BETAMETHASONE ACIBUTATE works by inhibiting the production of inflammatory mediators.

What drug class is BETAMETHASONE ACIBUTATE in?

BETAMETHASONE ACIBUTATE belongs to the Corticosteroid class. See all Corticosteroid drugs at /class/corticosteroid.

What development phase is BETAMETHASONE ACIBUTATE in?

BETAMETHASONE ACIBUTATE is in Phase 2.

Drug class: All Corticosteroid drugs
Therapeutic area: All drugs in Immunology

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