Last reviewed 2026-05-29 · How we verify

Azacortid (FLUAZACORT)

Phase 2 active Small molecule ✓ Verified May 2026

Azacortid (generic name: FLUAZACORT) is a fluazacort drug. It is currently in Phase 2 development.

Azacortid works by binding to a specific target in the body, although the exact target is unknown.

Azacortid, also known as FLUAZACORT, is a small molecule drug in the fluazacort class. Unfortunately, there is limited information available on this compound. It is not clear what specific target it binds to or what indications it has been approved for. As a result, its commercial status and key safety considerations are also unknown. Further research is needed to fully understand this compound.

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	FLUAZACORT
Drug class	fluazacort
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Azacortid is a key that fits into one of those locks. When it binds, it can affect how the cell works, but we don't know which lock it fits into or how it affects the cell's behavior. This is a simplified explanation of how small molecule drugs like Azacortid work.

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:

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

Frequently asked questions about Azacortid

What is Azacortid?

Azacortid (FLUAZACORT) is a fluazacort drug.

How does Azacortid work?

Azacortid works by binding to a specific target in the body, although the exact target is unknown.

What is the generic name of Azacortid?

FLUAZACORT is the generic (nonproprietary) name of Azacortid.

What drug class is Azacortid in?

Azacortid belongs to the fluazacort class. See all fluazacort drugs at /class/fluazacort.

What development phase is Azacortid in?

Azacortid is in Phase 2.

Drug class: All fluazacort drugs
Therapeutic area: All drugs in Other

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