Last reviewed 2026-06-01 · How we verify

AGX101

Angiex, Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

AGX101 is a Small molecule drug developed by Angiex, Inc.. It is currently in Phase 1 development. Also known as: ADC.

AGX101 is being studied in a Phase 1 clinical trial for its safety, tolerability, and preliminary activity in participants with advanced solid tumors, including cancer, advanced cancer, locally advanced carcinoma, metastatic solid tumor, and breast cancer. AGX101 is a TM4SF1 directed antibody drug conjugate.

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	AGX101
Also known as	ADC
Sponsor	Angiex, 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 to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors (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:

AGX101 CI brief — competitive landscape report
AGX101 updates RSS · CI watch RSS
Angiex, Inc. portfolio CI

Frequently asked questions about AGX101

What is AGX101?

AGX101 is a Small molecule drug developed by Angiex, Inc..

Who makes AGX101?

AGX101 is developed by Angiex, Inc. (see full Angiex, Inc. pipeline at /company/angiex-inc).

Is AGX101 also known as anything else?

AGX101 is also known as ADC.

What development phase is AGX101 in?

AGX101 is in Phase 1.

Manufacturer: Angiex, Inc. — full pipeline
Also known as: ADC

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