Drugs / Lu AG09222
last change Jun 2026 re-read 9 days ago

Lu AG09222

Monoclonal antibody

Developed for
migraine disorder · allergic rhinitis
Investigated by
H. Lundbeck A/S

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials · 1 met primary
Phase 1 NCT06578585 Sep 2024 → Jul 2025 migraine disorder H. Lundbeck A/S Completed No outcome recorded
Phase 1 NCT05304910 Mar → Oct 2022 migraine disorder H. Lundbeck A/S Completed No outcome recorded
Phase 1 NCT05126316 Nov 2021 → Jul 2022 allergic rhinitis H. Lundbeck A/S Completed No outcome recorded
Phase 1 NCT04976309 Jul → Sep 2021 — H. Lundbeck A/S Completed Met primary
Phase 22 trials · 1 met primary
Phase 2 NCT06323928 Apr 2024 → Jan 2026 migraine disorder H. Lundbeck A/S Completed No outcome recorded
Phase 2 NCT05133323 Nov 2021 → Jan 2023 migraine disorder H. Lundbeck A/S Completed Met primary
Comparator or background therapy1 trial
— NCT02158221 Comparator Jun → Nov 2014 migraine without aura Danish Headache Center Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-06-04 H. Lundbeck A/S Results Lundbeck presents positive Phase IIb data for bocunebart (Lu AG09222; anti-PACAP mAb) in migraine prevention at the AHS congress lundbeck.com ↗
The results from the intravenous dosing part of the PROCEED trial reinforce previously reported positive topline findings and further support the therapeutic potential of targeting the PACAP pathway in prevention of severe migraine.
2026-06-04 H. Lundbeck A/S Results Lundbeck Presents New VYEPTI® (eptinezumab-jjmr) and Bocunebart Migraine Data at the American Headache Society 68th Annual Scientific Meeting lundbeck.com ↗
Findings validate targeting PACAP for migraine prevention and support the

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Lu AG09222 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04976309 ↗
5

NCT05126316 ↗

NCT06578585 ↗

NCT05133323 ↗

NCT06323928 ↗

NCT05304910 ↗

Known as PACAP ClinicalTrials.gov intervention name — accepted as the source's own label NCT02158221 ↗
Known as Pituitary adenylate cyclase-activating polypeptide “Pituitary adenylate cyclase-activating polypeptide (PACAP)” NCT02158221 ↗
Action Inhibit “Lu AG09222 inhibited PACAP38-induced cephalic vasodilation and increases in heart rate, and reduced concomitant headache.” PMID 37231350 ↗ May 2023
Modality Peptide “PACAP is a neuropeptide” NCT02158221 ↗
Route Intravenous “PACAP intravenous infusion 1.5 microgram/min for 20 min” NCT02158221 ↗