Drug

Guadecitabine

As of the edition of 20 October 2026, Guadecitabine is a small molecule: stopped in 2023; acts on DNMT1.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Stopped, 2023
Kind
Small molecule
Registered trials
33, 3 stopped early
Disease areas
Cancer; Blood and lymph; Urinary and reproductive; Pregnancy and women's health; Digestive system; Hormones

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Guadecitabine.

Target

GeneProteinUniProt
DNMT1DNAP26358

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 19530
Phase 2211243
Phase 33300
All trials33

Who ran its trials

CompanyRoleYears
OtsukaLead sponsor of trials2011 to now
RocheLead sponsor of trials2016 to now