This section highlights FDA-related milestones and regulatory updates for drugs developed by Centessa Pharmaceuticals (CNTA).
Over the past two years, Centessa Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ORX142 and ORX750. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ORX142 - FDA Regulatory Timeline and Events
ORX142 is a drug developed by Centessa Pharmaceuticals for the following indication: A Novel Orexin Receptor 2 (OX2R) Agonist.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ORX142
- Announced Date:
- June 16, 2025
- Indication:
- A Novel Orexin Receptor 2 (OX2R) Agonist
Announcement
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers.
AI Summary
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application to start a Phase 1 clinical study of ORX142 in healthy volunteers. This study will focus on evaluating the safety, tolerability, and pharmacokinetics of ORX142 through single-ascending and multiple-ascending dose designs. Additionally, the trial includes a placebo-controlled, crossover pharmacodynamic assessment that utilizes the Maintenance of Wakefulness Test and Karolinska Sleepiness Scale in acutely sleep-deprived subjects.
ORX142 is an investigational, selective OX2R agonist being developed to treat certain neurological and neurodegenerative disorders. The study is planned to generate early proof-of-concept data and help determine an appropriate dose for future trials in patients. This milestone marks the beginning of a crucial new phase in Centessa’s efforts to explore a broader range of conditions with significant unmet needs.
Read Announcement- Drug:
- ORX142
- Announced Date:
- September 26, 2024
- Indication:
- A Novel Orexin Receptor 2 (OX2R) Agonist
Announcement
Centessa Pharmaceuticals plc today shared new preclinical data from non-human primate (NHP) studies of ORX142, an investigational, novel, orexin receptor 2 (OX2R) agonist being advanced for the treatment of excessive daytime sleepiness (EDS) in select neurological, neurodegenerative and psychiatric disorders.
AI Summary
Centessa Pharmaceuticals has shared new preclinical data from non-human primate studies of ORX142, an investigational orexin receptor 2 (OX2R) agonist. The data, presented at the Sleep Europe 2024 conference in Seville, Spain, showed that ORX142 significantly increases wakefulness at very low oral doses (0.03 mg/kg) in models that predict human responses. This novel compound works by activating the OX2R pathway, which is important for regulating the sleep-wake cycle.
The promising results highlight ORX142’s ability to maintain normal physiological arousal and promote alertness by reducing both REM and NREM sleep. Due to these encouraging findings, Centessa is accelerating ORX142 through IND-enabling studies as it advances this candidate for the treatment of excessive daytime sleepiness in select neurological, neurodegenerative, and psychiatric disorders.
Read Announcement- Drug:
- ORX142
- Announced Date:
- August 27, 2024
- Indication:
- A Novel Orexin Receptor 2 (OX2R) Agonist
Announcement
Centessa Pharmaceuticals plc announced that preclinical data from a non-human primate (NHP) study of ORX142, a highly potent and selective orexin receptor 2 (OX2R) agonist being developed to address excessive daytime sleepiness (EDS) in select neurological, neurodegenerative, and psychiatric disorders, has been accepted for a late- breaking poster presentation at the 27th Congress of the European Sleep Research Society (Sleep Europe 2024) being held September 24-27, 2024, in Seville, Spain.
AI Summary
Centessa Pharmaceuticals plc announced that new preclinical data from a non-human primate study on ORX142—a highly potent and selective orexin receptor 2 (OX2R) agonist—has been accepted for a late-breaking poster presentation at the 27th Congress of the European Sleep Research Society (Sleep Europe 2024) in Seville, Spain. The study demonstrated that even low doses of ORX142 effectively promoted wakefulness in non-human primates, supporting its potential to treat excessive daytime sleepiness (EDS) in select neurological, neurodegenerative, and psychiatric disorders.
The poster presentation, scheduled during the conference from September 24-27, 2024, marks a significant milestone in validating the compound's translational promise. These robust preclinical findings highlight ORX142’s potential to offer an innovative therapeutic approach for managing EDS, reinforcing Centessa’s commitment to developing next-generation treatments for sleep-wake disorders.
Read Announcement
ORX750 - FDA Regulatory Timeline and Events
ORX750 is a drug developed by Centessa Pharmaceuticals for the following indication: For the treatment of narcolepsy and other sleep disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ORX750
- Announced Date:
- March 6, 2025
- Indication:
- For the treatment of narcolepsy and other sleep disorders.
Announcement
Centessa Pharmaceuticals plc announced that data from the Phase 1 clinical trial of ORX750, an investigational novel highly potent and selective OX2R agonist being progressed for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), will be presented in a poster session at the American Academy of Neurology (AAN) 2025 Annual Meeting being held April 5-9, 2025, in San Diego, CA
AI Summary
Centessa Pharmaceuticals has announced that data from its Phase 1 clinical trial of ORX750, an investigational and highly potent OX2R agonist, will be presented at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego, CA. The drug is being developed for the treatment of sleep-wake disorders including narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. The poster presentation, titled “Phase 1 Clinical Data with Orexin Receptor 2 (OX2R) Agonist, ORX750, in Acutely Sleep-Deprived Healthy Participants,” will be led by Deborah Hartman, PhD, Global Scientific Head of the Orexin Program. It is scheduled for Saturday, April 5, 2025, from 11:45 AM to 12:45 PM, at booth number 627. Details of the poster will later be available on Centessa’s website after the presentation concludes.
Read Announcement- Drug:
- ORX750
- Announced Date:
- September 10, 2024
- Indication:
- For the treatment of narcolepsy and other sleep disorders.
Announcement
Centessa Pharmaceuticals plc announced positive interim data from an ongoing Phase 1 trial of its highly potent and selective orexin receptor 2 (OX2R) agonist, ORX750, in acutely sleep-deprived healthy volunteers.
AI Summary
Centessa Pharmaceuticals plc announced positive interim data from its ongoing Phase 1 trial of ORX750, a highly potent and selective orexin receptor 2 (OX2R) agonist. The study involved acutely sleep-deprived healthy volunteers and showed that the 2.5 mg dose of ORX750 significantly restored normative wakefulness, achieving a mean sleep latency of 32 minutes on the Maintenance of Wakefulness Test (MWT). This result represents a clear improvement compared to placebo and meets clinically meaningful benchmarks for wakefulness enhancement.
Additionally, ORX750 demonstrated a favourable safety and tolerability profile, with no observed on-target adverse events typically seen with other OX2R agonists, nor any cases of hepatotoxicity or visual disturbances. The pharmacokinetic profile supports once-daily dosing, and these promising results have provided the basis for rapidly advancing to Phase 2 studies later this year in patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
Read Announcement- Drug:
- ORX750
- Announced Date:
- April 22, 2024
- Indication:
- For the treatment of narcolepsy and other sleep disorders.
Announcement
Centessa Pharmaceuticals plc announced that The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.
AI Summary
Centessa Pharmaceuticals plc announced that dosing in healthy volunteers for its Phase 1 clinical trial of ORX750 is expected to begin imminently. The investigational drug is designed as a potent and selective orexin receptor 2 (OX2R) agonist aimed at treating narcolepsy and possibly other sleep-wake disorders. The trial will test safety, tolerability, and the drug’s behavior in the body by using single and multiple ascending dose assessments. Additionally, a crossover pharmacodynamic study will evaluate the ability of ORX750 to improve wakefulness through standard tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale.
The company projects that early proof-of-concept data will be available in the second half of 2024, which will help in selecting doses for future patient studies involving narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
Read Announcement- Drug:
- ORX750
- Announced Date:
- April 22, 2024
- Indication:
- For the treatment of narcolepsy and other sleep disorders.
Announcement
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy.
AI Summary
Centessa Pharmaceuticals plc recently received clearance from the U.S. Food and Drug Administration (FDA) to start a Phase 1 first-in-human clinical trial. This important step allows the company to begin evaluating ORX750, an investigational, orally administered orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy. The Phase 1 trial will look at the safety, tolerability, and how the drug is processed in the body using both single-ascending and multiple-ascending doses in healthy volunteers.
The study will also include tests aimed at checking ORX750’s drug effects on sleep latency and sleepiness in sleep-deprived subjects. Centessa is eager to start dosing soon and expects early proof-of-concept data by the second half of 2024. This milestone is seen as a promising step towards developing a new treatment for narcolepsy and possibly other sleep-wake disorders.
Read Announcement
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