DeepMed Research

Bitopertin

Generic Name: Bitopertin

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₀F_₇N_₃O_₄S

CAS Number: 845614-11-1

Unique Ingredient Identifier: Q8L6AN59YY

Background: Bitopertin has been used in trials studying the treatment of Schizophrenia and Obsessive-Compulsive Disorder.

Clinical Trials

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

Phase 3

Recruiting

Conditions: Erythropoietic Protoporphyria (EPP)
X-Linked Protoporphyria (XLP)

Interventions: Drug: Placebo
Drug: DISC-1459

First Posted Date: 2025-04-04

Last Posted Date: 2025-05-13

Lead Sponsor: Disc Medicine, Inc

Target Recruit Count: 150

Registration Number: NCT06910358

Locations: 🇺🇸
Marvel Clinical Research, Huntington Beach, California, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
MetroBoston Clinical Partners, Boston, Massachusetts, United States

and more 1 locations

Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with EPP

Phase 2

Conditions: Erythropoietic Protoporphyria

Interventions: Drug: DISC-1459

First Posted Date: 2023-06-01

Last Posted Date: 2024-11-15

Lead Sponsor: Disc Medicine, Inc

Target Recruit Count: 200

Registration Number: NCT05883748

Locations: 🇺🇸
University of Miami Miller School of Medicine, Miami, Florida, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Einstein Medical Center, Philadelphia, Pennsylvania, United States

and more 8 locations

Study of the Selective GlyT1 Inhibitor Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia

Phase 1

Recruiting

Conditions: Steroid-refractory Diamond-Blackfan Anemia (DBA)

Interventions: Drug: Bitopertin

First Posted Date: 2023-04-25

Last Posted Date: 2025-03-26

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 30

Registration Number: NCT05828108

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP

Phase 2

Active, not recruiting

Conditions: Erythropoietic Protoporphyria

Interventions: Drug: DISC-1459
Drug: Placebo

First Posted Date: 2022-04-04

Last Posted Date: 2024-04-15

Lead Sponsor: Disc Medicine, Inc

Target Recruit Count: 75

Registration Number: NCT05308472

Locations: 🇺🇸
Einstein Medical Center, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas, Galveston, Texas, United States
🇺🇸
Fred Hutchinson Cancer Center, Seattle, Washington, United States

and more 6 locations

A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia

Phase 2

Completed

Conditions: Beta-Thalassemia

Interventions: Drug: Bitopertin

First Posted Date: 2017-09-05

Last Posted Date: 2018-10-05

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 12

Registration Number: NCT03271541

Locations: 🇮🇹
Ospedale Maggiore di Milano; Cardio-Metabolic Diseases, Milano, Lombardia, Italy
🇹🇭
Siriraj Hospital; Division of Haematology-Oncology, Bangkok Noi, Thailand
🇱🇧
Chronic Care Center, Baabda, Lebanon

and more 1 locations

A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.

Phase 1

Withdrawn

Conditions: Healthy Volunteer

Interventions: Drug: Midazolam
Drug: bitopertin

First Posted Date: 2013-12-24

Last Posted Date: 2017-10-25

Lead Sponsor: Hoffmann-La Roche

Registration Number: NCT02019290

A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)

Phase 2

Completed

Conditions: Obsessive-Compulsive Disorder

Interventions: Drug: Bitopertin
Drug: Placebo
Drug: SSRI

First Posted Date: 2012-08-28

Last Posted Date: 2017-08-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 99

Registration Number: NCT01674361

Locations: 🇺🇸
Keystone Clinical Studies, LLC, Norristown, Pennsylvania, United States
🇺🇸
Compass Research North, LLC, Leesburg, Florida, United States
🇨🇦
McMaster University - MacAnxiety Research Centre, Hamilton, Ontario, Canada

and more 30 locations

A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: RO4917838
Drug: RO4927838

First Posted Date: 2012-08-16

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 16

Registration Number: NCT01665976

A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: bitopertin
Drug: placebo

First Posted Date: 2012-07-10

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 71

Registration Number: NCT01636492

A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: RO4917838
Drug: Moxifloxacin
Drug: RO4917838 placebo

First Posted Date: 2012-06-06

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 169

Registration Number: NCT01613040

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