Last reviewed 2026-05-19 · How we verify

AMP945 ascending doses

Amplia Therapeutics Limited · Phase 1 active Small molecule ✓ Verified May 2026 Quality 10/100

AMP945 ascending doses is a Small molecule drug developed by Amplia Therapeutics Limited. It is currently in Phase 1 development.

AMP945 is a small molecule being studied in a Phase 1b/2a clinical trial (NCT05355298) for the treatment of pancreatic cancer, specifically Pancreatic Ductal Adenocarcinoma (PDAC). The trial involves ascending doses of AMP945 to determine its pharmacokinetics, safety, and efficacy in combination with nab-paclitaxel and gemcitabine.

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	AMP945 ascending doses
Sponsor	Amplia Therapeutics Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

ACCENT: AMP945 in Combination with Nab-paclitaxel and Gemcitabine for Treatment of 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:

AMP945 ascending doses CI brief — competitive landscape report
AMP945 ascending doses updates RSS · CI watch RSS
Amplia Therapeutics Limited portfolio CI

Frequently asked questions about AMP945 ascending doses

What is AMP945 ascending doses?

AMP945 ascending doses is a Small molecule drug developed by Amplia Therapeutics Limited.

Who makes AMP945 ascending doses?

AMP945 ascending doses is developed by Amplia Therapeutics Limited (see full Amplia Therapeutics Limited pipeline at /company/amplia-therapeutics-limited).

What development phase is AMP945 ascending doses in?

AMP945 ascending doses is in Phase 1.

Manufacturer: Amplia Therapeutics Limited — full pipeline

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