Last reviewed 2026-05-26 · How we verify

XAF5, concentration B

Topokine Therapeutics, Inc. · Phase 1 active Small molecule ✓ Verified May 2026

XAF5, concentration B is a Small molecule drug developed by Topokine Therapeutics, Inc.. It is currently in Phase 1 development.

XAF5 is an ointment used in a Phase 2b/3 study for the treatment of Steatoblepharon, with a concentration B of 0.035%. The exact mechanism of action of XAF5 is unknown.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	XAF5, concentration B
Sponsor	Topokine Therapeutics, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags) (PHASE2, PHASE3)
Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers (PHASE1)

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:

XAF5, concentration B CI brief — competitive landscape report
XAF5, concentration B updates RSS · CI watch RSS
Topokine Therapeutics, Inc. portfolio CI

Frequently asked questions about XAF5, concentration B

What is XAF5, concentration B?

XAF5, concentration B is a Small molecule drug developed by Topokine Therapeutics, Inc..

Who makes XAF5, concentration B?

XAF5, concentration B is developed by Topokine Therapeutics, Inc. (see full Topokine Therapeutics, Inc. pipeline at /company/topokine-therapeutics-inc).

What development phase is XAF5, concentration B in?

XAF5, concentration B is in Phase 1.

Manufacturer: Topokine Therapeutics, Inc. — full pipeline

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