EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

Start Date01 Jan 2026

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

NCT07035197

/ RecruitingNot ApplicableIIT

Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)

This research study is designed as a longitudinal prospective descriptive study using mixed-method data collection. Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody (anti-CGRP mAb), is administered by intravenous (IV) infusion every 3 months as preventive medication for individuals with migraine who have been diagnosed based on theInternational Classification of Headache Disorders, 3rd edition (ICHD-3) by headache specialist neurologists. The goal of this study is to understand the real-life experiences of people with migraine who receive eptinezumab in a hospital setting in Thailand, a middle-income country. The researchers want to learn about what makes it easier or harder for patients and healthcare workers to use this treatment.
The main questions it aims to answer are:
* What are the barriers and facilitators to using eptinezumab from the perspectives of patients and healthcare providers?
* Does eptinezumab reduce monthly migraine days and improve quality of life over time?
Participants will:
* (For migraine patients) Take part in an in-depth interview (IDI) within 24 hours after receiving an eptinezumab infusion
* (For migraine patients) Complete questionnaires about migraine symptoms, disability, and quality of life at baseline, 3 months, and 6 months
* (For healthcare providers) Take part in a one-time interview about their experiences administering eptinezumab
The study will also look at how well eptinezumab works by measuring changes in monthly migraine days and other health scores over a 6-month period. The information from this study may help improve migraine care in Thailand and support better access to new treatments like eptinezumab.

Start Date25 Aug 2025

Sponsor / Collaborator

H. Lundbeck A/S

100 Clinical Results associated with Eptinezumab-JJMR

100 Translational Medicine associated with Eptinezumab-JJMR

100 Patents (Medical) associated with Eptinezumab-JJMR

249

Literatures (Medical) associated with Eptinezumab-JJMR

01 Jun 2026·SLEEP MEDICINE REVIEWS

Sleep and anti-calcitonin gene related peptide (CGRP) drugs: current evidence and perspectives

Review

Author: Romozzi, Marina ; Boccalini, Alberto ; Vernieri, Fabrizio ; Sebastianelli, Gabriele ; Geppetti, Pierangelo ; Ray, Sucharita ; Vigani, Giulia ; Altamura, Claudia ; Iannone, Luigi Francesco ; Viticchi, Giovanna

Migraine and sleep share a bidirectional relationship: sleep disruption can trigger migraine attacks, while migraine impairs sleep continuity and quality. Calcitonin gene-related peptide (CGRP), central to migraine pathophysiology, also contributes to sleep regulation through hypothalamic and brainstem circuits that control arousal and circadian rhythms. This overlap raises the question of whether pharmacological inhibition of CGRP with monoclonal antibodies (mAbs) or gepants could affect sleep. This scoping review summarizes evidence on anti-CGRP therapies and their impact on sleep quality, efficacy, and tolerability. Although results are inconsistent across instruments, emerging data suggest that anti-CGRP mAbs and gepants, particularly erenumab, galcanezumab, and atogepant, can improve subjective sleep quality and objective measures such as sleep efficiency in some cases. Evidence for fremanezumab and eptinezumab remains scarce, whereas large-scale pharmacovigilance datasets indicate low rates of insomnia, somnolence, or abnormal dreams. Overall, current findings suggest that CGRP inhibition impacts the sleep system, but the mechanisms of this interaction remain partly understood, representing a promising area for mechanistic exploration and clinical application. Future studies with standardized sleep endpoints are needed to distinguish direct neuropharmacological effects from indirect benefits mediated by improvement in migraine burden.

01 Apr 2026·Neurology and Therapy

Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial

Article

Author: Pozo-Rosich, Patricia ; Boserup, Line Pickering ; Lee, Xin Ying ; Tassorelli, Cristina ; Ailani, Jessica ; Awad, Susanne F

INTRODUCTION:

Psychiatric comorbidities increase the risk of migraine disease progression. These post hoc analyses explored whether self-reported psychiatric comorbidities at screening had an impact on the short- and long-term efficacy of eptinezumab in the DELIVER trial.

METHODS:

DELIVER was a multinational trial that evaluated eptinezumab in adults with migraine with 2-4 prior preventive treatment failures. Participants were initially randomized to intravenous eptinezumab 100 mg, 300 mg, or placebo every 12 weeks. Participants receiving placebo during the 24-week double-blind placebo-controlled period were switched to eptinezumab 100 mg or 300 mg for the 48-week dose-blinded extension, while those initially randomized to eptinezumab continued their assigned dose. Subgroups included participants self-reporting a psychiatric condition at screening, within which participants self-reporting a depressive condition at screening were also analyzed. Outcomes were changes from baseline in monthly migraine days (MMDs), ≥ 50% migraine responder rates (MRRs), and participants who improved per Patient Global Impression of Change (PGIC; much or very improved). As post hoc analyses, no p-values were generated.

RESULTS:

Of the total population, 122/890 (13.7%) self-reported ≥ 1 psychiatric comorbidity, including 68/890 (7.6%) who self-reported depression. The mean change from baseline in MMDs over Weeks 1-12 in the psychiatric comorbidity subgroup was - 4.6 with eptinezumab versus - 0.9 with placebo, with similar mean changes observed in those with comorbid depression (eptinezumab, - 4.7; placebo, 0.0). In the psychiatric comorbidity subgroup, ≥ 50% MRRs over Weeks 1-12 were higher with eptinezumab (42%; odds ratio [OR] vs placebo = 25.3) than with placebo (3%), as were the proportions of participants with PGIC improvement (eptinezumab, 60%, OR = 6.7; placebo, 19%). During the extension period, participants switching from placebo to eptinezumab reported similar improvements to the eptinezumab-eptinezumab group, with similar outcomes in the subgroups with psychiatric comorbidities.

CONCLUSIONS:

Psychiatric comorbidities, including depressive conditions, did not appear to impact the short- or long-term efficacy of eptinezumab in participants with migraine for whom 2-4 prior preventive treatments had failed.

TRIAL REGISTRATION:

EudraCT (2019-004497-25); ClinicalTrials.gov (NCT04418765).

01 Feb 2026·CEPHALALGIA

Levels of migraine controls following International Headache Society (IHS) recommendations with eptinezumab: Effectiveness and tolerability in a 24-week, prospective multicenter study (the TACHIS study)

Article

Author: Trimboli, Michele ; Grazzi, Licia ; Chiarugi, Alberto ; Munafò, Antonio ; Merlo, Paola ; Tassorelli, Cristina ; Albanese, Maria ; Coppola, Gianluca ; Piella, Elisa Maria ; Guerzoni, Simona ; Avino, Gianluca ; Fofi, Luisa ; Battistini, Stefania ; Romozzi, Marina ; Prudenzano, Maria Pia ; Marcosano, Marilena ; Vernieri, Fabrizio ; Altamura, Claudia ; Carlucci, Giovanna ; Doretti, Alberto ; Montisano, Danilo Antonio ; Lanni, Claudia ; Fasano, Carla ; Rainero, Innocenzo ; Vaghi, Gloria ; Geppetti, Pierangelo ; Sebastianelli, Gabriele ; De Cesaris, Francesco ; Iannone, Luigi Francesco ; Calabresi, Paolo ; Ornello, Raffaele ; Silvestro, Marcello ; Pistoia, Francesca ; de Tommaso, Marina ; Russo, Antonio ; Lo Castro, Flavia ; Rufa, Alessandra ; Ferrandi, Delfina ; Valente, Maria Rosaria ; Sacco, Simona ; De Icco, Roberto

Aim:

The TACHIS study (from the ancient Greek adjective “ tachýs ” meaning rapid) aimed to evaluate eptinezumab effectiveness and tolerability in routine clinical practice, integrating patient-reported outcomes and use of International Headache Society (IHS)-endorsed categories of migraine control by treatment.

Background:

Eptinezumab is the only intravenous anti-calcitonin gene related peptide (CGRP) monoclonal antibody (mAb) approved for migraine prevention. While its efficacy has been demonstrated in RCTs, real-world evidence in patients with prior preventive treatment failures is still limited.

Methods:

TACHIS is a prospective, multicenter, observational study conducted in Italy. Adults with episodic or chronic migraine initiating eptinezumab were followed for 24 weeks. Primary outcomes included change from baseline in monthly migraine days (MMDs) and ≥50% responder rate. Secondary outcomes included changes from baseline in acute medication use, Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) and IHS-defined residual burden categories. Logistic regression identified factors of response status.

Results:

A total of 128 patients were included (82% female; 82% chronic migraine). MMDs decreased overall by 5.7 days (95% CI: −7.2 to −4.3) at week 12 and 6.9 (95% CI: −8.5 to −5.2) at week 24 (p < 0.001). A ≥ 50% response was achieved in 43.8% and 48.2% of patients at weeks 12 and 24, respectively. Over 40% of patients achieved optimal or modest migraine control. CGRP targeted therapy-naïve patients experienced significant greater benefit, though non-naïve patients also improved. Female sex and chronic migraine diagnosis were independently associated with response at 12 weeks. Adverse events were infrequent (4.7%) and mild, with no discontinuations due to safety concerns.

Conclusions:

Eptinezumab demonstrated effectiveness and tolerability in a real-world population of patients with migraine and prior preventive treatment failures. The integration of migraine control metrics provides a comprehensive evaluation of therapeutic impact and supports eptinezumab use in routine care.

Trial Registration:

The TACHIS study was preregistered on clinicaltrial.gov, NCT06409845.

News (Medical) associated with Eptinezumab-JJMR

24 Feb 2026

·endpoints.news

New biotech Slate Medicines raises $130M for migraine drug from China

The latest in a parade of China-sourced startups will join the race to develop a new class of migraine drugs. On Tuesday, Slate Medicines announced that it had raised a $130 million Series A round, and has the non-China rights to a drug candidate from Guangdong-based DartsBio that is scheduled to enter Phase 1 this year. The round was led by RA Capital, Forbion and Foresite Capital, which have taken part in other, similar deals recently in which a new Western company is founded around an asset or pipeline from China-based drug developers. Slate’s deal marks the third China-to-West licensing deal in two days . Raleigh, NC-based Slate declined to disclose financial details of the deal with DartsBio. DartsBio, founded in 2017, has worked on clinical-stage medicines for pain and cancer-related complications. It’s also forged deals with other drugmakers, such as DualityBio . In the Slate deal, DartsBio will hand over the ex-China rights to a monoclonal antibody that targets pituitary adenylate cyclase-activating polypeptides, or PACAPs. The asset, renamed SLTE-1009, is expected to start Phase 1 testing outside of China around the middle of this year. The class had a key win in mid-stage testing earlier this month, when Lundbeck said its drug bocunebart beat placebo at reducing the number of monthly migraine days. The Danish drugmaker’s candidate is slated to enter Phase 3 later this year. Currently, the migraine prevention space is dominated by CGRP inhibitors like Nurtec ODT, Vyepti and Ajovy. Lundbeck’s EVP of R&D Johan Luthman has said the PACAP approach could go after a “broader spectrum of migraine biology.” Haywire signaling for PACAP can drive pain sensation, neurogenic inflammation and instigate migraines. Slate aims to differentiate from Lundbeck with a longer-lasting candidate that can be delivered subcutaneously at home. Slate’s chief medical officer Roger Cady was previously VP of neurology at Lundbeck. Leading the biotech is CEO Gregory Oakes, who helmed Landos Biopharma during its $137.5 million upfront deal with AbbVie in 2024. COO Neil Buckley is working alongside Oakes and Cady. Buckley and Oakes were both venture partners at RA Capital’s healthcare incubator called Raven.

License out/inPhase 1

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

100 Deals associated with Eptinezumab-JJMR

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eptinezumab-JJMR	L01XC	DB14040

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Lundbeck Seattle BioPharmaceuticals, Inc.	21 Feb 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Headache caused by drug	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	South Korea	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	China	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	South Korea	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Taiwan Province	H. Lundbeck A/S	17 Feb 2021
Cluster Headache	Phase 3	United States	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	Japan	H. Lundbeck A/S	23 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04418765 (DELIVER, Pubmed \| Neurol Ther)	Phase 3	Migraine Disorders	890	Eptinezumab 100 mg	qwsrhovycl(baxnpdfodx) = diswifruyw czqlthmjcr (steiajflgh ) View more	Positive	11 Feb 2026
				Placebo	qwsrhovycl(baxnpdfodx) = xhdibtjiaq czqlthmjcr (steiajflgh ) View more
NEWS Manual	Not Applicable	Migraine Disorders	111	Eptinezumab	jewmwjrlyi(inurxdkryr) = luhlswdeay zdepbhuoea (llscrkfwdf ) View more	Positive	30 Jan 2026
NCT05452239 (RESOLUTION, CTgov)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	608	Eptinezumab (Placebo-controlled Period: Eptinezumab)	voywdagcut(ulegasolhj) = aazflnaawh wwmwpgtsju (pdaztcxerm, 0.518) View more	-	04 Dec 2025
				placebo+eptinezumab (Placebo-controlled Period: Placebo)	voywdagcut(ulegasolhj) = zacdnkszjh wwmwpgtsju (pdaztcxerm, 0.519) View more
NCT04921384 (SUNRISE, Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	978	Eptinezumab 100 mg	-	Positive	01 Oct 2025
				Eptinezumab 300 mg
NCT05064371 (SUNSET, PRNewswire) Manual	Phase 3	Migraine Disorders	159	Eptinezumab 100 mg	mxnnxmochn(eelqhuvygp) = qbpfswotye mkamigrita (nqlkcqgwnu )	Positive	11 Sep 2025
				Eptinezumab 300 mg	-
RESOLUTION (PRNewswire) Manual	Phase 4	Migraine Disorders \| Headache	608	brief educational intervention (BEI) + eptinezumab	yewzhtyqgk(vondssyyro) = eusfftrcwk qxltyhmjfs (yqotqiioob ) View more	Positive	11 Sep 2025
				brief educational intervention (BEI) + placebo	-
NCT04688775 (ALLEVIATE, Pubmed \| JAMA Neurol) Manual	Phase 3	Cluster Headache	231	Eptinezumab 400 mg	ncbxwcjinu(qxffvhwmte) = gxeasuxahr wrjnurmuvs (pricccmgpc, 8.1) View more	Positive	01 Jul 2025
				Placebo	ncbxwcjinu(qxffvhwmte) = jgosxawlcz wrjnurmuvs (pricccmgpc, 8.3) View more
AAN2025	Phase 3	Migraine Disorders Maintenance	858	Eptinezumab 100 mg	oaszadhozd(dyhuwntqwg) = thvggumaia ccuugyaoqi (rnmyqcjwsq ) View more	Positive	07 Apr 2025
				Eptinezumab 300 mg	oaszadhozd(dyhuwntqwg) = brnlrqeucf ccuugyaoqi (rnmyqcjwsq ) View more
P12-12.010 (AAN2025)	Not Applicable	Migraine Disorders	94	Eptinezumab (≥75% increase in good days/month)	uwjvlxxbfg(yieznqvpon) = varguswjbd pllgmzigcn (izghzbszlp )	Positive	07 Apr 2025
				Eptinezumab (<75% increase in good days/month)	uwjvlxxbfg(yieznqvpon) = fwahegzega pllgmzigcn (izghzbszlp )
AAN2025	Phase 3	Migraine Disorders	128	Eptinezumab 300 mg	gdtdjqchjv(wjcivqkujf) = vnuzzgbjwv vcfthgwdfr (ayeghygrbp ) View more	Positive	07 Apr 2025

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