Last reviewed 2026-06-01 · How we verify

ABT-301

Anbogen Therapeutics, Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 0/100

ABT-301 is a Small molecule drug developed by Anbogen Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: MPT0E028, Imofinostat.

ABT-301 is being studied in combination with tislelizumab and bevacizumab for the treatment of locally advanced or metastatic colorectal cancer. The exact mechanism of ABT-301 is currently 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	ABT-301
Also known as	MPT0E028, Imofinostat
Sponsor	Anbogen 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

A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC (PHASE1, 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:

ABT-301 CI brief — competitive landscape report
ABT-301 updates RSS · CI watch RSS
Anbogen Therapeutics, Inc. portfolio CI

Frequently asked questions about ABT-301

What is ABT-301?

ABT-301 is a Small molecule drug developed by Anbogen Therapeutics, Inc..

Who makes ABT-301?

ABT-301 is developed by Anbogen Therapeutics, Inc. (see full Anbogen Therapeutics, Inc. pipeline at /company/anbogen-therapeutics-inc).

Is ABT-301 also known as anything else?

ABT-301 is also known as MPT0E028, Imofinostat.

What development phase is ABT-301 in?

ABT-301 is in Phase 1.

Manufacturer: Anbogen Therapeutics, Inc. — full pipeline
Also known as: MPT0E028, Imofinostat

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