Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORX750 · 2 trials · 3 indications
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Number of Participants With Abnormal Change From Baseline in Vital Signs
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
| Arm | Type | Description |
|---|---|---|
| Narcolepsy Type 1 | EXPERIMENTAL | Narcolepsy Type 1 (Open Label) |
| Narcolepsy Type 2 | EXPERIMENTAL | Narcolepsy Type 2 (Open Label) |
| Idiopathic Hypersomnia | EXPERIMENTAL | Idiopathic Hypersomnia (Open Label) |
| Narcolepsy Type 1: ORX750 and Placebo | EXPERIMENTAL | - |
| Narcolepsy Type 2: ORX750 and Placebo | EXPERIMENTAL | - |
| Idiopathic Hypersomnia: ORX750 and Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ORX750 | DRUG | Oral ORX750 |
| Placebo | DRUG | ORX750 matching placebo capsule. |
Inclusion Criteria: * Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1) * Is willing and able to adhere to additional protocol requirements Exclusion Criteria: * Development of any new disea...
ORX750 is an investigational small molecule being developed for the treatment of Narcolepsy Type 1. It is currently in Phase 2 clinical trials, which also include participants with Narcolepsy Type 2 and Idiopathic Hypersomnia. The drug is being studied as a potential therapy to address symptoms associated with these sleep disorders.
ORX750 targets the OX2R receptor, which is the orexin 2 receptor. This receptor plays a role in regulating wakefulness and sleep. By targeting OX2R, ORX750 is designed to potentially modulate the orexin system, which is implicated in narcolepsy and related hypersomnia conditions.
ORX750 is being developed by Centessa Pharmaceuticals plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol CNTA. Centessa is advancing ORX750 through clinical development for sleep disorders, including Narcolepsy Type 1.
ORX750 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 2 trials are actively recruiting participants to evaluate the drug's safety and efficacy in narcolepsy and idiopathic hypersomnia.
ORX750 is being studied in two Phase 2 clinical trials. The first trial, NCT06752668, is a study in participants with narcolepsy and idiopathic hypersomnia, with an enrollment of 248. The second trial, NCT07096674, is a long-term extension study with an enrollment of 90. Both trials are currently recruiting.
ORX750 is a distinct investigational drug and is not known to be the same as any other marketed medication. It is being developed specifically for narcolepsy and idiopathic hypersomnia. No alternative names for ORX750 have been identified in the available clinical trial information.