Last reviewed 2026-05-29 · How we verify

OCTABENZONE

Phase 2 active Small molecule ✓ Verified May 2026

OCTABENZONE is a drug. It is currently in Phase 2 development.

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

Octabenzone is a small molecule with the synonyms BENZOPHENONE-12, NSC-163400, OCTABENZONA, OCTABENZONE, and OCTABENZONE.

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	OCTABENZONE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells as a complex network of roads and intersections. Small molecules like octabenzone are like special keys that can unlock specific intersections, allowing different cellular processes to communicate with each other. However, the exact roads and intersections that octabenzone interacts with are still unknown.

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:

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

Frequently asked questions about OCTABENZONE

What is OCTABENZONE?

OCTABENZONE is a Small molecule drug.

How does OCTABENZONE work?

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

What development phase is OCTABENZONE in?

OCTABENZONE is in Phase 2.

Therapeutic area: All drugs in Other

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