Last reviewed 2026-04-20 · How we verify

Haloart (HALOPREDONE ACETATE)

Phase 2 active Small molecule

Haloart (generic name: HALOPREDONE ACETATE) is a halopredone drug. It is currently in Phase 2 development.

Haloart works by binding to the glucocorticoid receptor, a protein that regulates the body's response to stress and inflammation.

Haloart, also known as halopredone acetate, is a small molecule halopredone that targets the glucocorticoid receptor. Its mechanism of action and commercial status are not well-documented, and it is unclear if it is FDA-approved or off-patent. As a result, there is limited information available on its approved indications, half-life, and bioavailability. Further research is needed to fully understand the properties and uses of Haloart. It is not currently possible to provide a comprehensive summary of this medication.

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	HALOPREDONE ACETATE
Drug class	halopredone
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Think of the glucocorticoid receptor like a switch that controls how the body responds to stress and inflammation. When Haloart binds to this switch, it can help to reduce inflammation and other symptoms associated with certain medical conditions. This can be helpful for people who are experiencing conditions like arthritis or asthma.

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:

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

Frequently asked questions about Haloart

What is Haloart?

Haloart (HALOPREDONE ACETATE) is a halopredone drug.

How does Haloart work?

Haloart works by binding to the glucocorticoid receptor, a protein that regulates the body's response to stress and inflammation.

What is the generic name of Haloart?

HALOPREDONE ACETATE is the generic (nonproprietary) name of Haloart.

What drug class is Haloart in?

Haloart belongs to the halopredone class. See all halopredone drugs at /class/halopredone.

What development phase is Haloart in?

Haloart is in Phase 2.

What does Haloart target?

Haloart targets Glucocorticoid receptor and is a halopredone.

Drug class: All halopredone drugs
Target: All drugs targeting Glucocorticoid receptor
Therapeutic area: All drugs in Immunology

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