Last reviewed 2026-06-02 · How we verify

Bexarotene Capsules

Acrotech Biopharma Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

Bexarotene Capsules is a Small molecule drug developed by Acrotech Biopharma Inc.. It is currently in Phase 1 development. Also known as: Bexarotene, Targretin®.

Bexarotene capsules are used to treat refractory cutaneous T-cell lymphoma, as well as metastatic breast cancer. According to ChEMBL, bexarotene acts as a retinoid X receptor (RXR) agonist, which is a type of nuclear receptor involved in cell growth and differentiation.

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	Bexarotene Capsules
Also known as	Bexarotene, Targretin®
Sponsor	Acrotech Biopharma Inc.
Modality	Small molecule
Phase	Phase 1

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:

Bexarotene Capsules CI brief — competitive landscape report
Bexarotene Capsules updates RSS · CI watch RSS
Acrotech Biopharma Inc. portfolio CI

Frequently asked questions about Bexarotene Capsules

What is Bexarotene Capsules?

Bexarotene Capsules is a Small molecule drug developed by Acrotech Biopharma Inc..

Who makes Bexarotene Capsules?

Bexarotene Capsules is developed by Acrotech Biopharma Inc. (see full Acrotech Biopharma Inc. pipeline at /company/acrotech-biopharma-inc).

Is Bexarotene Capsules also known as anything else?

Bexarotene Capsules is also known as Bexarotene, Targretin®.

What development phase is Bexarotene Capsules in?

Bexarotene Capsules is in Phase 1.

Manufacturer: Acrotech Biopharma Inc. — full pipeline
Also known as: Bexarotene, Targretin®

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