Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Start Date13 Sep 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT06323928

/ Active, not recruitingPhase 2

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Start Date01 Apr 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT05304910

/ CompletedPhase 1

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Properties of Lu AG09222 in Healthy Caucasian, Chinese and Japanese Subjects

The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.

Start Date18 Mar 2022

Sponsor / Collaborator

H. Lundbeck A/S

100 Clinical Results associated with Bocunebart

100 Translational Medicine associated with Bocunebart

100 Patents (Medical) associated with Bocunebart

Literatures (Medical) associated with Bocunebart

01 Sep 2025·Reproductive Sciences

Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) Alleviates the Defective Epididymis and Sperm Function in Lipopolysaccharide (LPS) Induced Acute Mouse Epididymitis

Article

Author: Xuexia, Liu ; Fujun, Liu ; Benjiao, Gong ; Xiaoxin, Wang ; Xueying, Zhang ; Yanan, Liu

This study investigated the protective effects of pituitary adenylate cyclase-activating polypeptide (PACAP) against lipopolysaccharide (LPS)-induced acute epididymitis in mice, with a particular emphasis on its antioxidant and anti-inflammatory mechanisms within the epididymal microenvironment responsible for sperm maturation. Acute epididymitis was triggered by injecting LPS intraperitoneally, with concurrent PACAP administration. Epididymal tissues were collected for histological, immunofluorescence, RT-PCR, and in vitro fertilization analyses. The results demonstrated that PACAP markedly decreased the expression of Il-6 mRNA (2.87 fold decrease, p < 0.05) and Tnf-α mRNA (2.45 fold decrease, p < 0.05) in the cauda epididymis following LPS adminstration for 6 h, alleviated histopathological changes, and improved sperm motility (from 37.8 ± 4.1% in LPS group to 52.7 ± 3.3% in LPS + PACAP group, p < 0.05) and morphology (abnormal sperm rate decreased from 45.7% ± 5.6-22.1% ± 3.8%, p < 0.05). PACAP also preserved the expression of epididymal function-associated proteins (AQP1 and KRT5), suppressed inflammatory gene expression, and enhanced antioxidant gene expression in the cauda epididymidis tissues during acute epididymitis. In vitro fertilization experiments revealed that PACAP significantly restored sperm fertilizing capacity, as evidenced by an increase in sperm-oocyte binding (from 8.7 ± 1.5 to 15.6 ± 2.7, p < 0.05), and improved embryonic development rates compromised by LPS (the two-cell embryo rate increased from 35.7% ± 4.8-62.3% ± 5.1%, p < 0.05). These results demonstrated that PACAP exerted a protective effect by suppressing inflammation and oxidative stress in acute epididymitis, thereby preserving epididymal function and sperm quality. PACAP may represent a potential therapeutic agent for epididymitis and related fertility issues.

01 Aug 2025·BRAIN

PACAP and migraine

Article

Author: Diener, Hans Christoph

Abstract:

A number of neuropeptides, including pituitary adenylate cyclase-activating polypeptide (PACAP), play an important role in the pathophysiology of migraine. Infusions of PACAP in patients with migraine can provoke migraine attacks. A placebo-controlled study with a monoclonal antibody directed against the PACAP-receptor failed to show efficacy. In a small, short, proof-of-concept study, a monoclonal antibody directed against PACAP (Lu AG09222) showed efficacy in reducing monthly migraine days compared to placebo but failed for the end point 50% reduction in migraine days. The ongoing PROCEED study, a double-blind, placebo-controlled, dose-finding study investigating four different doses of Lu AG09222 versus placebo for migraine prevention, is expected to complete in the second half of 2025.

05 Sep 2024·NEW ENGLAND JOURNAL OF MEDICINE

A Monoclonal Antibody to PACAP for Migraine Prevention

Article

Author: Ashina, Messoud ; Florea, Ioana ; Phul, Ravinder ; Löf, Elin ; Khodaie, Melanie

BACKGROUND:

Targeting pituitary adenylate cyclase-activating polypeptide (PACAP) is a new avenue for treating migraine. The efficacy and safety of intravenous Lu AG09222, a humanized monoclonal antibody directed against the PACAP ligand, for migraine prevention are unclear.

METHODS:

In a phase 2, double-blind, randomized, placebo-controlled trial, we enrolled adult participants (18 to 65 years of age) with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a 4-week treatment period and an 8-week follow-up period. Participants were randomly assigned in a 2:1:2 ratio to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo. The primary end point was the mean change from baseline in the number of migraine days per month, during weeks 1 through 4, in the Lu AG09222 750-mg group as compared with the placebo group.

RESULTS:

Of 237 participants enrolled, 97 received 750 mg of Lu AG09222, 46 received 100 mg of Lu AG09222, and 94 received placebo. The mean number of baseline migraine days per month was 16.7 in the overall population, and the mean change from baseline over weeks 1 through 4 was -6.2 days in the Lu AG09222 750-mg group, as compared with -4.2 days in the placebo group (difference, -2.0 days; 95% confidence interval, -3.8 to -0.3; P = 0.02). Adverse events with a higher incidence in the Lu AG09222 750-mg group than in the placebo group during the 12-week observation period included coronavirus disease 2019 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%).

CONCLUSIONS:

In a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. (Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.).

News (Medical) associated with Bocunebart

13 Feb 2026

·endpoints.news

Lundbeck's migraine prevention drug succeeds in Phase 2, advancing new therapy class

Lundbeck said its next-generation migraine prevention drug cleared the bar in a Phase 2b study, setting the company up for late-stage trials that could start this year. The Danish drugmaker said the IV-delivered medicine, bocunebart (Lu AG09222), was better than placebo at reducing the number of monthly migraine days that patients experienced during a 12-week review. The results were statistically significant. To be included in the trial, dubbed PROCEED , patients had to have failed one to four migraine prevention drugs over the past 10 years. The company didn’t share details such as the scope of the migraine reductions or exactly how the drug and placebo performed relative to each other. It said the drug was “generally well-tolerated” and plans to share more details later. A spokesperson for Lundbeck declined to comment on exactly when the company aims to begin Phase 3 testing of bocunebart. Last March, the company set the second half of 2026 as its goal. Lundbeck hopes bocunebart can open up a new class of migraine prevention drugs. It already markets the migraine medicine Vyepti, which targets CGRP and brought in 4.47 billion DKK ($711 million) last year. The company is competing with multiple other migraine drugs such as Aimovig, Ajovy, Emgality and Nurtec. Bocunebart belongs to a class targeting pituitary adenylate cyclase-activating peptides, or PACAPs, and the company thinks it could address a “broader spectrum of migraine biology” than other treatments for the condition, EVP of R&D Johan Luthman said on an earnings call last November. Abnormal signaling for PACAP can influence pain sensation, neurogenic inflammation and help stoke migraines, Lundbeck has said in presentations. If successful, it could be the first anti-PACAP migraine prevention drug. Eli Lilly dumped a monoclonal antibody targeting that pathway in 2022. Other migraine mechanisms are on the horizon. In December, New York-based Kallyope said its TRPM8 antagonist elismetrep hit the mark in a Phase 2b migraine trial. That drug is entering Phase 3 and could be sent to regulators for review in 2028, CEO Jay Galeota told Endpoints News in December. If bocunebart eventually succeeds, it likely won’t get to market in time to immediately help offset Lundbeck’s looming patent cliffs. About 60% of Lundbeck’s 2025 revenues will run into generic competition between 2026 and 2029, according to a note earlier this month from Jefferies. “The issues at the company are straightforward, not new, and very typical of many other large pharma companies these days, as managements race to build credible pipelines to replace sales from key LOE assets,” Leerink analyst Marc Goodman wrote in a Feb. 4 note to clients. Some of Lundbeck’s earlier-stage medicines could have critical readouts later this year, including experimental medicines for Parkinson’s disease, thyroid eye disease and other indications.

Phase 2Phase 3Clinical Result

12 Feb 2026

·www.fiercebiotech.com

Lundbeck’s migraine prevention treatment sees ph. 2 success after trial’s earlier setback

The results come from the multiple IV dosing portion of the trial, coded Proceed.\n After Lundbeck scrapped one portion of its trial, the company\'s intravenous monoclonal antibody has met the main goal of a phase 2b migraine prevention study, with multiple doses of the experimental treatment tied to a change in monthly migraine days.While the pharma didn’t share the data behind the result, the company said the dose-finding trial demonstrated a statistically significant difference compared to placebo in the number of monthly migraine days (MMDs) reported over 12 weeks among 431 patients who hadn’t responded to past preventative treatments.The investigational antibody was also well tolerated, according to Lundbeck. The pharma plans to share data behind the results at an upcoming conference.Based on the findings, the Danish pharma plans on discussing phase 3 design options with regulators. “These data underline Lundbeck’s ambition to deliver the first PACAP targeting option in migraine prevention,” Johan Luthman, Ph.D., EVP and head of R&D at Lundbeck, said in a Feb. 12 release.“With its novel mechanism of action, it has the potential to become an important addition to the migraine treatment paradigm, furthering Lundbeck’s mission to improve outcomes for people living with severe migraine,” Luthman said.The results come from the multiple IV dosing portion of the trial, coded Proceed. The study was also examining multiple doses of bocunebart via injection, but Lundbeck stopped development in the delivery method last year after reviewing the study data. The company launched the trial in 2024, in part to determine the best route of administration for bocunebart (also known as Lu AG09222), an anti-PACAP antibody. The success of single IV administration for bocunebart had prompted Lundbeck to assess whether subcutaneous delivery was viable, but a prespecified interim futility analysis of the subcutaneous data put an end to that assessment.The subcutaneous method in migraines has proven challenging for other players, as well.A few years ago, Amgen reported no benefit over placebo for its monoclonal antibody targeting the PAC1 receptor, while Eli Lilly stopped development of its anti-PACAP antibody after phase 2.Elsewhere in the migraine prevention field, Lundbeck markets the infused drug Vyepti in the crowded CGRP inhibitor space. The drug, which is administered every three months, hit the scene in 2020 to challenge subcutaneous big pharma rivals in Amgen\'s Aimovig, Eli Lilly\'s Emgality and Teva\'s Ajovy.Last year, Vyepti pulled down $710 million worldwide, a 59% increase from 2024, according to a recent earnings report (PDF).

Clinical ResultPhase 2Drug ApprovalPhase 3

12 Feb 2026

·firstwordpharma.com

Biopharma bites: Lundbeck posts mid-stage migraine win, AbbVie sues to stop Botox pricing talks

Lundbeck eyes Phase III for anti-PACAP mAb in migraine preventionAbbVie sues over Botox's inclusion in Medicare price negotiationsLundbeck eyes Phase III for anti-PACAP mAb in migraine preventionLundbeck reported positive top-line results from the Phase IIb PROCEED migraine prevention trial evaluating bocunebart (Lu AG09222), an investigational mAb targeting pituitary adenylate cyclase-activating polypeptide (PACAP).The IV dosing portion of the study met its primary endpoint, significantly reducing monthly migraine days compared to placebo over weeks one to 12. The trial includes patients who have experienced one to four preventive treatment failures in the past 10 years. Participants received monthly treatment with bocunebart or placebo over three months.Bocunebart was generally well tolerated, with no new safety signals identified. The results build on earlier Phase IIa findings from the HOPE study evaluating a single IV administration of bocunebart. PROCEED aimed to establish the drug's optimal dose and route of administration, either subcutaneous or IV.Lundbeck said bocunebart could eventually become a first-in-class therapy as the PACAP signaling pathway is mechanistically distinct from established anti-CGRP migraine drugs. "Based on this positive outcome, [we] will approach regulatory authorities to discuss the results and Phase III design options," the company added.-Anna BratulicAbbVie sues over Botox's inclusion in Medicare price negotiationsAbbvie has filed suit against the US Department ‌of Health and Human Services (HHS), challenging the decision made by the Centers ⁠for Medicare & Medicaid Services (CMS) to include Botox in the third iteration of drug pricing talks held under the US Inflation Reduction Act (IRA).While the first two rounds only included pharmacy-dispensed drugs covered under Medicare Part D, the latest slate of therapeutics, announced in January, includes several — like Botox — that are covered by Part B when administered by a physician.As part of its fourth-quarter earnings report this month, AbbVie said sales for therapeutic Botox grew 13.4% to $990 million. However, analysts weren't expecting Botox and its $1.1 billion in Medicare spending to be named in the latest IRA list, leaving them sceptical the pharma can hit its long-term revenue projections for the product (see – Vital Signs: The bark may be gone from IRA, but can it still bite?).-Elizabeth Eaton

Clinical ResultPhase 3Phase 2

100 Deals associated with Bocunebart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Disorders	Phase 2	United States	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Czechia	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Denmark	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Georgia	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Poland	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Slovakia	H. Lundbeck A/S	11 Nov 2021
Rhinitis, Allergic, Seasonal	Phase 1	United Kingdom	H. Lundbeck A/S	01 Nov 2021
Headache	Phase 1	Denmark	H. Lundbeck A/S	15 Jul 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05133323 (Literature \| Pubmed \| N Engl J Med) Manual	Phase 2	Migraine Disorders	237	Lu AG09222 750 mg	jjnhnfvoqq(fiffwdqyzt) = hoongfyncx royxuljtvq (kvsacycrri ) View more	Positive	04 Sep 2024
				Lu AG09222 100 mg	-
NCT05133323 (CTgov)	Phase 2	Migraine Disorders	237	Lu AG09222 (Lu AG09222 High Dose)	vovhmoixsn(qljilxayyq) = tfrrgarlon bpolcqjgmt (eackwavlbb, 0.66) View more	-	08 Feb 2024
				Lu AG09222 (Lu AG09222 Low Dose)	vovhmoixsn(qljilxayyq) = bjsqsaldri bpolcqjgmt (eackwavlbb, 0.94) View more
NCT04976309 (Pubmed \| J Headache Pain) Manual	Phase 1	Migraine Disorders	25	Lu AG09222 + PACAP38 + VIP	dqvjbucpps(cndtegsdnr) = vujsttsulq ididrzlbdh (nknbllttah, 3.96)	Positive	25 May 2023
				placebo + PACAP38 + VIP	dqvjbucpps(cndtegsdnr) = tddrguoywe ididrzlbdh (nknbllttah, 13.0)

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