Bitopertin
Sponsors
Disc Medicine Inc., Hoffmann-La Roche, National Heart, Lung, and Blood Institute (NHLBI), Wake Forest University Health Sciences
Conditions
Beta-ThalassemiaErythropoietic Protoporphyria (EPP)Healthy VolunteerObsessive-Compulsive DisorderProtoporphyriaSchizophreniaSteroid-refractory Diamond-Blackfan Anemia (DBA)X-Linked Protoporphyria (XLP)
Phase 1
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
CompletedNCT01636492
Start: 2005-11-30End: 2006-08-31Updated: 2016-11-02
A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.
WithdrawnNCT02019290
Start: 2014-02-10End: 2014-03-31Updated: 2017-10-25
Study of the Selective GlyT1 Inhibitor Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia
CompletedNCT05828108
Start: 2023-07-25End: 2025-08-28Updated: 2026-02-17
Effect of Bitopertin on the Liver and on Levels of Protoporphyrin IX in Bile, Blood, Liver, and Stool in Patients With Erythropoietic Protoporphyria/X-linked Protoporphyria and Increased Liver Stiffness and/or Liver Enzymes at Baseline
WithdrawnNCT07123363
Start: 2026-01-01End: 2035-12-01Updated: 2026-01-29
Phase 2
A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
CompletedNCT01674361
Start: 2012-12-31End: 2015-04-30Updated: 2017-08-02
A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia
CompletedNCT03271541
Start: 2017-10-26End: 2018-06-29Updated: 2018-10-05
Phase 3
A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
CompletedNCT01192880
Start: 2010-11-30End: 2014-07-31Updated: 2017-02-15
APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants with
Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
RecruitingCTIS2024-520407-27-00
Start: 2025-10-23Target: 56Updated: 2025-12-08
HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP).
Not yet recruitingCTIS2025-523275-27-00
Target: 21Updated: 2026-02-13