Drug

Molidustat

As of the edition of 20 October 2026, Molidustat is a small molecule: marketed, first approved in 2021 (JP); acts on EGLN1.

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

The drug

Status
Marketed; latest approval 2021
Kind
Small molecule
Brand name
Musredo
First approved
22 January 2021 (JP)
Approvals on record
2 in 1 region
Holder of the most recent approval
Bayer
Registered trials
16, 0 stopped early
Disease areas
Blood and lymph; Pregnancy and women's health; Urinary and reproductive

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 Molidustat.

Target

GeneProteinUniProt
EGLN1Egl nine homolog 1Q9GZT9

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1010
Phase 15500
Phase 25500
Phase 35500
All trials16

Who has held its approvals

CompanyRoleYears
BayerApplicant and Lead sponsor of trials2011 to now