Last reviewed 2026-05-18 · How we verify

DUR-928 Topical Solution

Durect · Phase 2 active Small molecule Quality 25/100

DUR-928 Topical Solution is a Small molecule drug developed by Durect. It is currently in Phase 2 development.

The precise mechanism of action for DUR-928 topical formulation has not been publicly disclosed.

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	DUR-928 Topical Solution
Sponsor	Durect
Modality	Small molecule
Phase	Phase 2

Mechanism of action

DUR-928 is an endogenous sulfated oxysterol. While the systemic formulation has been studied for its potential anti-inflammatory and tissue-protective properties, the specific mechanism for the topical formulation remains undisclosed.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis (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:

DUR-928 Topical Solution CI brief — competitive landscape report
DUR-928 Topical Solution updates RSS · CI watch RSS
Durect portfolio CI

Frequently asked questions about DUR-928 Topical Solution

What is DUR-928 Topical Solution?

DUR-928 Topical Solution is a Small molecule drug developed by Durect.

How does DUR-928 Topical Solution work?

The precise mechanism of action for DUR-928 topical formulation has not been publicly disclosed.

Who makes DUR-928 Topical Solution?

DUR-928 Topical Solution is developed by Durect (see full Durect pipeline at /company/durect).

What development phase is DUR-928 Topical Solution in?

DUR-928 Topical Solution is in Phase 2.

Manufacturer: Durect — full pipeline

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