Last reviewed 2026-05-18 · How we verify

AXP107-11

Axcentua Pharmaceuticals AB · Phase 1 active Small molecule Quality 0/100

AXP107-11 is a Small molecule drug developed by Axcentua Pharmaceuticals AB. It is currently in Phase 1 development. Also known as: genistein.

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	AXP107-11
Also known as	genistein
Sponsor	Axcentua Pharmaceuticals AB
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

AXP107-11 in Combination With Standard Gemcitabine (Gemzar® ) Therapy for Treatment in Patients With Pancreatic Cancer (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:

AXP107-11 CI brief — competitive landscape report
AXP107-11 updates RSS · CI watch RSS
Axcentua Pharmaceuticals AB portfolio CI

Frequently asked questions about AXP107-11

What is AXP107-11?

AXP107-11 is a Small molecule drug developed by Axcentua Pharmaceuticals AB.

Who makes AXP107-11?

AXP107-11 is developed by Axcentua Pharmaceuticals AB (see full Axcentua Pharmaceuticals AB pipeline at /company/axcentua-pharmaceuticals-ab).

Is AXP107-11 also known as anything else?

AXP107-11 is also known as genistein.

What development phase is AXP107-11 in?

AXP107-11 is in Phase 1.

Manufacturer: Axcentua Pharmaceuticals AB — full pipeline
Also known as: genistein

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