---
schema_version: "secwatch.filing_event.v1"
accession: "0001847903-24-000069"
form_type: "8-K"
ticker: "CNTA"
cik: "0001847903"
company_name: "Centessa Pharmaceuticals plc"
filed_at: "2024-04-22T23:59:59+00:00"
generated_at: "2026-06-03T14:24:23.077980+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Centessa's ORX750 Phase 1 trial in narcolepsy; PoC data expected 2H 2024

## Summary
- FDA cleared IND for ORX750, an oral OX2R agonist targeting narcolepsy type 1 (NT1), NT2, and idiopathic hypersomnia.
- Phase 1 study includes SAD, MAD, and cross-over PoC using Maintenance of Wakefulness Test and Karolinska Sleepiness Scale in sleep-deprived healthy volunteers.
- FDA-set maximum exposure limit significantly exceeds predicted efficacious doses; no impact on planned development.
- Dosing to begin imminently; proof-of-concept data anticipated in second half of 2024.

## SEC filing metadata
- accession: 0001847903-24-000069
- form_type: 8-K
- ticker: CNTA
- cik: 0001847903
- company_name: Centessa Pharmaceuticals plc
- filed_at: 2024-04-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1847903/000184790324000069/0001847903-24-000069-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1847903/000184790324000069/cnta-20240422.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001847903-24-000069
- JSON: https://secwatch.observer/filing/0001847903-24-000069.json
- Plain text: https://secwatch.observer/filing/0001847903-24-000069.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.