Last reviewed 2026-05-20 · How we verify

Etiprednol Dichloroacetate (ETIPREDNOL DICLOACETATE)

Phase 2 active Small molecule ✓ Verified May 2026

Etiprednol Dichloroacetate (generic name: ETIPREDNOL DICLOACETATE) is a drug. It is currently in Phase 2 development.

Etiprednol Dichloroacetate is a small molecule that works by interacting with specific biological pathways, but the exact mechanism is unknown.

Etiprednol dichloroacetate is a small molecule with the synonyms BNP-166, dicloacetate d'etiprednol, and others.

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	ETIPREDNOL DICLOACETATE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Etiprednol Dichloroacetate is a key that fits into those locks. When it binds to the locks, it can either open or close the cell's activity, depending on the specific lock and key interaction. However, the exact way it interacts with these locks is still a mystery.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Multicenter Trial For Patients With Acute Crohn's Disease (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Etiprednol Dichloroacetate CI brief — competitive landscape report
Etiprednol Dichloroacetate updates RSS · CI watch RSS

Frequently asked questions about Etiprednol Dichloroacetate

What is Etiprednol Dichloroacetate?

Etiprednol Dichloroacetate (ETIPREDNOL DICLOACETATE) is a Small molecule drug.

How does Etiprednol Dichloroacetate work?

Etiprednol Dichloroacetate is a small molecule that works by interacting with specific biological pathways, but the exact mechanism is unknown.

What is the generic name of Etiprednol Dichloroacetate?

ETIPREDNOL DICLOACETATE is the generic (nonproprietary) name of Etiprednol Dichloroacetate.

What development phase is Etiprednol Dichloroacetate in?

Etiprednol Dichloroacetate is in Phase 2.

Therapeutic area: All drugs in Other

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