Last reviewed 2026-04-20 · How we verify

Gemcitabine plus PM060184

PharmaMar · Phase 1 active Small molecule Quality 20/100

Gemcitabine plus PM060184 is a Small molecule drug developed by PharmaMar. It is currently in Phase 1 development.

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	Gemcitabine plus PM060184
Sponsor	PharmaMar
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Neutropenia
Anaemia
Nausea
Asthenia
Fatigue
Pyrexia
Weight decreased
Epistaxis
Dizziness
Paraesthesia
Peripheral sensory neuropathy
Abdominal pain

Key clinical trials

Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients 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:

Gemcitabine plus PM060184 CI brief — competitive landscape report
Gemcitabine plus PM060184 updates RSS · CI watch RSS
PharmaMar portfolio CI

Frequently asked questions about Gemcitabine plus PM060184

What is Gemcitabine plus PM060184?

Gemcitabine plus PM060184 is a Small molecule drug developed by PharmaMar.

Who makes Gemcitabine plus PM060184?

Gemcitabine plus PM060184 is developed by PharmaMar (see full PharmaMar pipeline at /company/pharmamar).

What development phase is Gemcitabine plus PM060184 in?

Gemcitabine plus PM060184 is in Phase 1.

What are the side effects of Gemcitabine plus PM060184?

Common side effects of Gemcitabine plus PM060184 include Neutropenia, Anaemia, Nausea, Asthenia, Fatigue, Pyrexia.

Manufacturer: PharmaMar — full pipeline

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