Last reviewed 2026-06-01 · How we verify

RX-0201 plus Gemcitabine

Rexahn Pharmaceuticals, Inc. · Phase 2 active Small molecule ✓ Verified Jun 2026

RX-0201 plus Gemcitabine is a Small molecule drug developed by Rexahn Pharmaceuticals, Inc.. It is currently in Phase 2 development.

RX-0201 is being studied in combination with Gemcitabine for the treatment of Metastatic Pancreatic Cancer. The mechanism of RX-0201 is currently unknown.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	RX-0201 plus Gemcitabine
Sponsor	Rexahn Pharmaceuticals, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer (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:

RX-0201 plus Gemcitabine CI brief — competitive landscape report
RX-0201 plus Gemcitabine updates RSS · CI watch RSS
Rexahn Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about RX-0201 plus Gemcitabine

What is RX-0201 plus Gemcitabine?

RX-0201 plus Gemcitabine is a Small molecule drug developed by Rexahn Pharmaceuticals, Inc..

Who makes RX-0201 plus Gemcitabine?

RX-0201 plus Gemcitabine is developed by Rexahn Pharmaceuticals, Inc. (see full Rexahn Pharmaceuticals, Inc. pipeline at /company/rexahn-pharmaceuticals-inc).

What development phase is RX-0201 plus Gemcitabine in?

RX-0201 plus Gemcitabine is in Phase 2.

Manufacturer: Rexahn Pharmaceuticals, Inc. — full pipeline

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