About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

DISC-1459

Company: Disc Medicine, Inc
Mechanism: Mechanism not yet reported
Route: Route not yet reported
Recruiting trials: None currently listed

Efficacy results: Not yet reported

No recruiting studies currently listed

See all studies for this drug

Data source: ClinicalTrials.gov · trial data as of Sep 11, 2026

Trial details

Completed NCT NCT00616798

A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

Not yet reported Hoffmann-La Roche 323 participants Est. completion 2010-02 73 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01116830

A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

Not yet reported Hoffmann-La Roche 29 participants Est. completion 2014-02 1 site Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01183585

A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Not yet reported Hoffmann-La Roche 18 participants Est. completion 2010-09 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01192867

A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

Not yet reported Hoffmann-La Roche 629 participants Est. completion 2014-05-26 122 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01192880

A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

Not yet reported Hoffmann-La Roche 625 participants Est. completion 2014-07 103 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01192906

A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

Not yet reported Hoffmann-La Roche 624 participants Est. completion 2014-07 113 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01234779

A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

Not yet reported Hoffmann-La Roche 301 participants Est. completion 2012-09 46 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01235520

A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

Not yet reported Hoffmann-La Roche 595 participants Est. completion 2014-07 121 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01235559

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

Not yet reported Hoffmann-La Roche 604 participants Est. completion 2015-03 90 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01235585

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

Not yet reported Hoffmann-La Roche 597 participants Est. completion 2014-09 120 sites Stand-alone

Other conditions: Schizophrenia
View official trial listing →
Completed NCT NCT01356550

A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

Not yet reported Hoffmann-La Roche 35 participants Est. completion 2011-10 3 sites Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01365403

A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

Not yet reported Hoffmann-La Roche 16 participants Est. completion 2011-07 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01433575

A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

Not yet reported Hoffmann-La Roche 16 participants Est. completion 2011-11 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01438749

A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

Not yet reported Hoffmann-La Roche 177 participants Est. completion 2012-05 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01495104

A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

Not yet reported Hoffmann-La Roche 18 participants Est. completion 2012-01 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01510899

A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Not yet reported Hoffmann-La Roche 12 participants Est. completion 2012-03 3 sites Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01543529

A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

Not yet reported Hoffmann-La Roche 25 participants Est. completion 2012-06-04 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01613040

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

Not yet reported Hoffmann-La Roche 169 participants Est. completion 2009-07 2 sites Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01636492

A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Not yet reported Hoffmann-La Roche 71 participants Est. completion 2006-08 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01665976

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

Not yet reported Hoffmann-La Roche 16 participants Est. completion 2012-11 1 site Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT01674361

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

Not yet reported Hoffmann-La Roche 99 participants Est. completion 2015-04-30 34 sites Stand-alone

Other conditions: Obsessive-Compulsive Disorder
View official trial listing →
Withdrawn NCT NCT02019290

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

Not yet reported Hoffmann-La Roche Est. completion 2014-03-31 Stand-alone

Other conditions: Healthy Volunteer
View official trial listing →
Completed NCT NCT03271541

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

Not yet reported Hoffmann-La Roche 12 participants Est. completion 2018-06-29 4 sites Stand-alone

Other conditions: Beta-Thalassemia
View official trial listing →
Completed NCT NCT05308472

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

Not yet reported Disc Medicine, Inc 75 participants Est. completion 2024-08-23 9 sites Stand-alone

Other conditions: Erythropoietic Protoporphyria
View official trial listing →
Completed NCT NCT05828108

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

Not yet reported, Not yet reported National Heart, Lung, and Blood Institute (NHLBI) 15 participants Est. completion 2025-08-28 1 site Stand-alone

Other conditions: Steroid-refractory Diamond-Blackfan Anemia (DBA)
View official trial listing →
Enrolling by invitation NCT NCT05883748

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

Not yet reported, Not yet reported Disc Medicine, Inc 230 participants Est. completion 2028-06 26 sites Stand-alone

Other conditions: Erythropoietic Protoporphyria
View official trial listing →
Active, not recruiting NCT NCT06910358

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

Not yet reported Disc Medicine, Inc 183 participants Est. completion 2026-10 27 sites Stand-alone

Other conditions: Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
View official trial listing →
Withdrawn NCT NCT07123363

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

Not yet reported Wake Forest University Health Sciences Est. completion 2035-12 Stand-alone

Other conditions: Protoporphyria
View official trial listing →
Available NCT NCT07603401

Expanded Access Program of Bitopertin For Participants With EPP or XLP

Disc Medicine, Inc 5 sites

Other conditions: Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
View official trial listing →

Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

ClinicalTrials.gov — NCT06910358

Also known as: DISC-1459, Bitopertin, RO4917838

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.