Molidustat

Generic Name: Molidustat

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₄N_₈O_₂

CAS Number: 1154028-82-6

Unique Ingredient Identifier: 9JH486CZ13

Background: Molidustat is under investigation in clinical trial NCT03350321 (A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects).

Clinical Trials

A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

Active, not recruiting

Conditions: Renal Anemia

Interventions: Drug: Molidustat (Musredo, BAY85-3934)

First Posted Date: 2021-05-24

Last Posted Date: 2025-04-25

Lead Sponsor: Bayer

Target Recruit Count: 1500

Registration Number: NCT04899661

Locations: 🇯🇵
Many facilities, Multiple Locations, Japan

Maintenance Treatment of Renal Anemia in Dialysis Subjects

Phase 3

Completed

Conditions: Renal Insufficiency, Chronic
Anemia

Interventions: Drug: Molidustat (BAY85-3934)
Drug: Darbepoetin alfa
Drug: Placebo of Molidustat (BAY85-3934)
Drug: Placebo of Darbepoetin alfa

First Posted Date: 2018-06-01

Last Posted Date: 2021-01-29

Lead Sponsor: Bayer

Target Recruit Count: 229

Registration Number: NCT03543657

Locations: 🇯🇵
Chibune Clinic, Osaka, Japan
🇯🇵
Maruko Central Hospital, Ueda, Nagano, Japan
🇯🇵
Houshikai Kano hospital, Kasuya-gun, Fukuoka, Japan

and more 50 locations

A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects

Phase 3

Completed

Conditions: Anemia
Renal Insufficiency, Chronic

Interventions: Drug: Molidustat (BAY85-3934)

First Posted Date: 2018-02-01

Last Posted Date: 2021-01-29

Lead Sponsor: Bayer

Target Recruit Count: 51

Registration Number: NCT03418168

Locations: 🇯🇵
Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan
🇯🇵
Fukushima Medical University Hospital, Fukushima, Japan
🇯🇵
Asahi University Hospital, Gifu, Japan

and more 24 locations

A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects

Phase 3

Completed

Conditions: Anemia
Renal Insufficiency, Chronic

Interventions: Drug: Molidustat (BAY85-3934)
Drug: Darbepoetin alfa

First Posted Date: 2017-11-22

Last Posted Date: 2021-01-29

Lead Sponsor: Bayer

Target Recruit Count: 164

Registration Number: NCT03350347

Locations: 🇯🇵
Matsunami Health Promotion Clinic, Hashima-gun, Gifu, Japan
🇯🇵
Mazda Hospital of Mazda Motor Corporation, Aki-gun, Hiroshima, Japan
🇯🇵
Higashihiroshima Medical Center, Higashihiroshima, Hiroshima, Japan

and more 56 locations

A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

Phase 3

Completed

Conditions: Anemia
Renal Insufficiency, Chronic

Interventions: Drug: Molidustat (BAY85-3934)
Drug: Darbepoetin alfa

First Posted Date: 2017-11-22

Last Posted Date: 2021-01-29

Lead Sponsor: Bayer

Target Recruit Count: 162

Registration Number: NCT03350321

Locations: 🇯🇵
Steel Memorial Yawata Hospital, Kitakyushu, Fukuoka, Japan
🇯🇵
St.Mary's Hospital, Kurume, Fukuoka, Japan
🇯🇵
Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan

and more 58 locations

A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

Phase 3

Completed

Conditions: Renal Insufficiency, Chronic
Anemia

Interventions: Drug: Molidustat (BAY85-3934)

First Posted Date: 2017-11-22

Last Posted Date: 2021-01-29

Lead Sponsor: Bayer

Target Recruit Count: 25

Registration Number: NCT03351166

Locations: 🇯🇵
Houshikai Kano hospital, Kasuya-gun, Fukuoka, Japan
🇯🇵
Asahikawa-Kosei General Hospital, Asahikawa, Hokkaido, Japan
🇯🇵
Ishikari Hospital, Ishikari, Hokkaido, Japan

and more 17 locations

Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

Phase 2

Completed

Conditions: Renal Insufficiency, Chronic
Anemia

Interventions: Biological: Epoetin alfa/beta
Drug: Molidustat (BAY85-3934)

First Posted Date: 2014-02-17

Last Posted Date: 2019-09-20

Lead Sponsor: Bayer

Target Recruit Count: 88

Registration Number: NCT02064426

Long-term Pre-dialysis Extension in Europe and Asia Pacific

Phase 2

Completed

Conditions: Anemia
Renal Insufficiency, Chronic

Interventions: Drug: Molidustat (BAY85-3934)
Biological: Darbepoetin

First Posted Date: 2014-02-05

Last Posted Date: 2017-11-22

Lead Sponsor: Bayer

Target Recruit Count: 166

Registration Number: NCT02055482

Locations: 🇹🇷
Baskent University Medical Faculty, Ankara, Turkey
🇹🇷
Ankara Univ. Medical Faculty, Ankara, Turkey
🇹🇷
Sifa University Medical Faculty, Izmir, Turkey

15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

Phase 2

Completed

Conditions: Anemia
Renal Insufficiency, Chronic

Interventions: Drug: BAY85-3934
Drug: Placebo

First Posted Date: 2013-12-27

Last Posted Date: 2019-09-20

Lead Sponsor: Bayer

Target Recruit Count: 121

Registration Number: NCT02021370

Locations: 🇹🇷
Sifa University Medical Faculty, Izmir, Turkey
🇹🇷
Ankara Univ. Medical Faculty, Ankara, Turkey
🇹🇷
Baskent University Medical Faculty, Ankara, Turkey

Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

Phase 2

Completed

Conditions: Renal Insufficiency, Chronic
Anemia

Interventions: Drug: BAY85-3934
Biological: Darbepoetin alfa

First Posted Date: 2013-12-27

Last Posted Date: 2019-09-19

Lead Sponsor: Bayer

Target Recruit Count: 126

Registration Number: NCT02021409

Locations: 🇹🇷
Baskent University Medical Faculty, Ankara, Turkey
🇹🇷
Ankara Univ. Medical Faculty, Ankara, Turkey
🇹🇷
Sifa University Medical Faculty, Izmir, Turkey

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy