The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, infections) and maternal (headache) outcomes for dyads in which the mother was treated with galcanezumab and to compare outcomes for infants who were or were not breastfed after maternal treatment.
In this prospective observational study, the study team proposes to prospectively collect serial milk samples from 30 adult women who are treated with galcanezumab for migraine. Mothers who are interested in participating will be connected with us, the main clinical site, by neurologists across the USA. Mothers must carry a diagnosis of migraine, be aged 18-45 years, and be between 14 days and 9 months postpartum, and still nursing, at the time of enrollment.
This study will fill a significant unmet need as women of childbearing potential are over-represented in the migraine population, and yet they are excluded from clinical trials of migraine treatments during pregnancy and lactation.

Start Date01 Dec 2023

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT05492695

/ TerminatedPhase 4

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

Start Date01 Oct 2022

Sponsor / Collaborator

Diamond Headache Clinic, Ltd.

NCT05281770

/ RecruitingNot ApplicableIIT

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

Start Date01 Oct 2022

Sponsor / Collaborator

Medical University of Vienna

[+1]

100 Clinical Results associated with Galcanezumab-gnlm

100 Translational Medicine associated with Galcanezumab-gnlm

100 Patents (Medical) associated with Galcanezumab-gnlm

448

Literatures (Medical) associated with Galcanezumab-gnlm

01 Feb 2025·Neurology Clinical Practice

Efficacy and Tolerability of Anti-CGRP Monoclonal Antibodies in Patients Aged ≥ 65 Years With Daily or Nondaily Migraine

Article

Author: Biswas, Sudipa ; Hogue, Olivia ; Ahmed, Zubair ; Salim, Amira ; Mata, Ignacio F. ; Sonneborn, Claire ; Suneja, Aarushi ; Mays, Maryann ; Hennessy, Elise

Background and ObjectivesDespite decreasing prevalence of migraine with advancing age, there remains a significant proportion of individuals aged ≥65 years with migraine. Treatment of this population is difficult and they are often excluded from clinical trials, limiting evidence regarding migraine treatment outcomes. Our objective is to assess the efficacy and tolerability of anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) therapies (erenumab, fremanezumab, and galcanezumab) in patients ≥65 years (O65) compared with patients <65 (U65) with daily or nondaily migraine.MethodsThis observational study uses retrospective data from the electronic medical records of patients who were treated with an anti-CGRP mAb between June 2018 and November 2021. Efficacy was determined through a reduction in monthly migraine days (MMDs) and Headache Impact Test (HIT-6) scores from baseline to posttreatment. Tolerability was examined through the number of adverse events reported per group. Mann-Whitney tests were used to compare the efficacy and tolerability of U65 and O65 patients overall and separated into daily and nondaily migraine groups.ResultsThe dataset consisted of U65 (n = 2,707; median [interquartile range]; 45.4 [35.8-53.8] years) or O65 (n = 304; 69.5 [67.3-73.3] years) and further separated into daily (n = 1,303) and nondaily (n = 1,708) migraine. There was no difference (p = 0.57) in the median MMD reduction between U65 (10 days [0.0-17.0]) and O65 (10 days [0.0-16.5]). Similarly, no difference was found among patients with nondaily migraine (p = 0.82) and patients with daily migraine (p = 0.59). HIT-6 scores decreased from severe to moderate/substantial impact for all groups. The daily and nondaily groups showed differences in meeting the 50% improvement threshold (nondaily U65, 67% vs daily U65, 54%, p < 0.0001; nondaily O65, 65% vs daily O65, 49%, p = 0.008). Side effects were reported (829/3,011), with a higher incidence in the U65 (22% O65, 28% U65). The most common side effects for both groups were injection site reaction/rash (40%) and constipation (25%).DiscussionThis retrospective analysis provides real-world evidence that there is no difference in the efficacy and tolerability of treatment with erenumab, fremanezumab, and galcanezumab in patients O65 when compared with patients U65 both with daily or nondaily migraine. These data may help guide the choice of migraine treatment in older populations.

02 Jan 2025·Neurological Research

Efficacy and safety of galcanezumab for cluster headache preventive treatment: a systematic review and meta-analysis

Review

Author: Baroni Coelho de Oliveira Ferreira, Domênica ; Mendieta, Cristian D. ; Aguiar Nogueira-Rosa, Lívia ; Moraes-Figueiredo, Nathalia ; Barbosa da Silva, Marina ; Pereira da Silva, Hamilcar

BACKGROUNDGalcanezumab is a monoclonal antibody targeting the CGRP pathway and represents the latest disease-specific and mechanism-based therapeutic option for cluster headache (CH).OBJECTIVEWe performed a systematic review and meta-analysis to evaluate the efficacy and safety of galcanezumab for CH.METHODSWe searched PubMed, Embase, and Cochrane Library for studies implementing galcanezumab for episodic and chronic CH. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Reporting Guidelines for Meta-analyses of Observational Studies (MOOSE) guidelines. The primary outcome was efficacy, defined by a reduction from the baseline of at least 50% in the weekly frequency of CH attacks and the Patient Global Impression of Improvement scale (PGI-I). Secondary outcomes included treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).RESULTSA total of 504 patients were included from 6 studies, of which 2 were RCTs. The follow-up period ranged from 3 weeks to 15 months. The mean age was 44.4 ± 10.2 years, with 24.4% female patients. Overall efficacy was 76.0% (95% CI 0.67-0.85), TEAEs were observed in 48.0% of patients (95% CI 0.25-0.72), and the most common were nasopharyngitis, local injection pain, and local injection swelling. TEAEs were, however, considerably higher within the 300 mg dose group compared with the 240 mg dose group, 80.0% (95% CI 0.65-0.87) versus 28.0% (95% CI 0.12-0.47), respectively.CONCLUSIONThis meta-analysis suggests that galcanezumab is effective in reducing the number of CH attacks and can be considered a safe medication.

01 Jan 2025·Headache: The Journal of Head and Face Pain

Persistence, effectiveness, and tolerability of anti‐calcitonin gene–related peptide monoclonal antibodies in patients with chronic migraine

Article

Author: Pagès‐Puigdemont, Neus ; de Dios, Anna ; Riera, Pau ; Ojeda, Sergio ; Morollon, Noemí ; Belvís, Robert ; Pelegrín, Rebeca ; Masip, Montserrat ; Real, Jordi

AbstractObjectiveTo evaluate, in patients with chronic migraine (CM) in real‐world conditions, the persistence, effectiveness, and tolerability of erenumab, fremanezumab, and galcanezumab anti‐calcitonin gene–related peptide (anti‐CGRP) monoclonal antibodies (mAbs) and the persistence and effects of switching.BackgroundAnti‐CGRP mAbs represent a novel therapeutic approach to the management of CM; however, real‐world data on persistence, effectiveness, and tolerability, especially after switching, are scarce.MethodsThis was a retrospective observational cohort study including all patients with CM treated with erenumab, fremanezumab, and/or galcanezumab in a tertiary hospital between January 2019 and December 2022. Treatment persistence was measured as the number of days between treatment start and end dates or the end of follow‐up and also as a percentage of persistent patients at 3, 6, and 12 months; effectiveness as a ≥50% reduction in monthly migraine days (MMD); and tolerability as the number and type of adverse events.ResultsIncluded were 281 patients (383 treatments) with CM (91.5% [257/281] female) receiving anti‐CGRP mAbs. Median (interquartile range [IQR]) treatment persistence was 267 (103–550) days. At 12 months, persistence was greater for the first (66.7%) compared to the second (49.8%) and third (37.2%) anti‐CGRP mAb treatments (hazard ratio [HR] = 1.93, 95% confidence interval [CI]: 1.35–2.74; HR = 2.75, 95% CI: 1.69–4.47, respectively). Persistence minimum observed median (IQR) was also greater for the first (291 [112–594] days) compared to both the second (188 [90–403] days; p < 0.001) and third (167 [89–352] days; p < 0.001) anti‐CGRP mAb treatments. For the first anti‐CGRP mAb treatment, there were no differences in persistence among the different drugs. In terms of effectiveness of the first, second, and third anti‐CGRP mAb treatments, a ≥50% reduction in MMD was achieved by 57.6% (117/203), 25.0% (11/44), and 11.8% (2/17) of patients, respectively, at 3 months, and by 55.8% (87/156), 29.6% (8/27), and 12.5% (1/8) of patients, respectively, at 6 months. At 12 months, no significant effectiveness differences were observed among anti‐CGRP mAb treatments. As for tolerability, 55 adverse events were reported by 43 (15.3%) patients, mostly mild and leading to treatment discontinuation in only 14 (5.0%) patients. The most common adverse events were constipation, injection site reaction, and pruritus. Erenumab patients (3%, 3/99) experienced a higher rate of discontinuation for constipation.ConclusionsOur findings showed a 12‐month higher treatment persistence with the use of a first anti‐CGRP mAb treatment when the switch to a second treatment was due to ineffectiveness or severe side events. This persistence was lower after a second or third anti‐CGRP. Additionally, in terms of effectiveness, the first anti‐CGRP treatment achieved a higher response in terms of ≥50% reduction in MMD; however, some patients may benefit from a switching strategy. Finally, the tolerability profile for anti‐CGRP mAbs was favorable. Further studies are needed to identify predictors of response after switching from the first anti‐CGRP mAb treatment.

News (Medical) associated with Galcanezumab-gnlm

19 Sep 2024

·www.pharmaceutical-technology.com

Organon makes $1.2bn play for Roivant’s immuno-dermatology subsidiary

The deal includes a $175m upfront payment for Roivant’s subsidiary Dermavant. Image credit: Shutterstock / testing. Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant in a potential $1.2bn deal. Organon will pay $175m upfront for the business as part of the transaction, which is expected to close in the fourth quarter of this year, as per an 18 September press release. Shares in both Organon and Roivant were down at close compared to their respective market opening prices on the day of the announcement. The bulk of the deal comes in the form of Dermavant’s plaque psoriasis treatment Vtama (tapinarof) The steroid cream is currently under review by the US Food and Drug Administration (FDA) for a label expansion into atopic dermatitis (AD) – if this goes through, Organon will pay Dermavant a milestone payment of $75m. Based on how Vtama does commercially, Dermavant could also be in line for a further $950m of milestone payments. See Also: Pioneering ePRO and eCOA innovations for next-generation clinical trials Dermavant’s lead asset Vtama won FDA approval for plaque psoriasis in May 2022. The drug brought in modest US sales of $78m in 2023 for Roivant, though its quarter-on-quarter growth has been underwhelming. Whilst psoriasis affects eight million people in the US aged 20 and older, AD affects 16.5 million adults in the country, and a further 9.6 million children have the condition. An FDA clearance for AD would open Vtama to a US market predicted to be worth $13.5bn by 2030, according to analysis by GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. Vtama boasted strong results in a Phase III trial for AD earlier this year, with 51% of 728 patients achieving complete disease clearance following 48-week use of the cream. The supplemental new drug application (sNDA) would allow Vtama’s use in adults and children two years of age and older with the inflammatory skin condition – the Prescription Drug User Fee Act (PDUFA) action is expected in the fourth quarter of this year. Organon’s CEO Kevin Ali said: “We look forward to combining Dermavant’s strong dermatology commercial and field medical organisation in the US, with Organon’s market access capabilities, regulatory expertise and worldwide commercial reach.” The deal follows several bolt-on deals by Organon recently, including purchasing US rights to Eli Lilly’s migraine medications Emgality (galcanezumab) and Rayvow (lasmiditan) for $50m in December last year . The deal was updated, giving more rights to Organon for Emgality, for $22.5m last month . While the Dermavant acquisition marks a dermatology expansion for Organon in the US, it also signals the second time in just over a year that Roivant has sold a subsidiary. Roivant earned $7.1bn from Roche when the latter bought its immunology company Telavant in December last year.

Phase 3Drug ApprovalAcquisitionClinical ResultNDA

05 Sep 2024

·www.pharmaceutical-technology.com

Lilly and EVA Pharma to expand baricitinib access in Africa

The agreement is part of Lilly’s 30×30 strategy. Credit: rafa press/Shutterstock. Eli Lilly and EVA Pharma have formed a partnership to increase the availability of baricitinib in 49 low to middle-income African countries by 2030. Baricitinib is a Janus kinase (JAK) inhibitor indicated for Covid-19, adults with severe alopecia areata and those with moderately to severely active rheumatoid arthritis who have not responded adequately to tumour necrosis factor blockers. The initiative is part of Lilly’s 30×30 strategy, which seeks to enhance health care for 30 million people in resource-limited areas annually by 2030. Incyte discovered baricitinib, which is licensed to Lilly and marketed under the brand name Olumiant. The collaboration will utilise EVA Pharma’s high-containment facility, which is poised to begin distributing locally manufactured baricitinib by 2026 to the agreed territories. See Also: UK NHS launches vaccine programme for RSV Novavax wins FDA emergency approval for updated Covid-19 vaccine The agreement will leverage the pan-African network of EVA Pharma and its local production capabilities, which adhere to international standards. This enables Lilly to extend the medicine’s reach to regions where access to such treatments is often limited. Lilly International executive vice-president and president Ilya Yuffa stated: “Our commitment to expanding access to affordable and innovative medicines for people living in low to middle-income countries continues. “Following our collaboration with EVA Pharma on insulin manufacturing, we are now establishing the first of its kind voluntary licensing agreement for Lilly, where the company will provide certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply baricitinib to people in 49 countries across Africa.” EVA Pharma has been collaborating with Lilly since 2021 to ensure a consistent supply of essential medicines in a number of African nations. The two companies are working together to enhance the affordability and accessibility of insulin in 56 primarily low to middle-income countries, as disclosed in 2022. EVA Pharma CEO Riad Armanious stated: “We are proud to localise the entire value chain of this critical medication on the continent, from producing high-potency baricitinib active pharmaceutical ingredients to tackling complex manufacturing challenges.” The latest development comes after Lilly expanded a commercial agreement , under which Organon will be the sole distributor and promoter of the migraine medication Emgality (galcanezumab) in 11 new markets.

VaccineLicense out/inDrug Approval

21 Aug 2024

·www.pharmaceutical-technology.com

Organon and Lilly expand deal for migraine treatment to new markets

Organon will distribute and promote the migraine treatment. Credit: Volodymyr TVERDOKHLIB/Shutterstock. Organon and Eli Lilly and Company have broadened their commercial agreement under which the former will be the sole distributor and promoter of the migraine medication Emgality (galcanezumab) in 11 new markets. The expanded territories are Canada, Colombia, Israel, Kuwait, Mexico, Qatar, Saudi Arabia, South Korea, Taiwan, Turkey and the United Arab Emirates. The financial terms of the deal include an upfront payment of $22.5m to Lilly, accompanied by additional sales-based milestone payments. The deal builds on Organon’s existing distribution responsibilities for the asset in Europe since February 2024. Organon CEO Kevin Ali stated: “The broadening of this agreement is a testament to Organon’s best-in-class commercialisation capabilities, global footprint and deep expertise in women’s health. See Also: Innovent’s Dupert approved in China to treat lung cancer Pathalys secures $105m to advance SHPT drug through approval “We know that migraine ranks as the leading cause of disability among young women and we’re proud to expand our offering to more women and men around the world living with episodic or chronic migraine.” A humanised monoclonal antibody, Emgality acts as a calcitonin gene-related peptide antagonist. It is designed as a preventive treatment for migraines in adults. In certain markets, it is specifically indicated for patients experiencing at least four migraine days per month. The medicine is also approved for treating episodic cluster headaches in adults in some regions. Under the expanded agreement, Organon will assume full distribution and promotional responsibilities for Emgality in the newly added markets. Lilly will retain its role as the marketing authorisation holder and continue manufacturing the product for sale. Eli Lilly and Company executive vice-president and Lilly International president Ilya Yuffa stated: “We are thrilled to expand this collaboration agreement with Organon. “We’re confident in our shared mission to bring this important migraine treatment to more patients around the world.” The development comes after Eli Lilly concluded the acquisition of Morphic Holding for $3.2bn, aimed at bolstering its inflammatory bowel disease portfolio.

Drug ApprovalAcquisitionLicense out/in

100 Deals associated with Galcanezumab-gnlm

External Link

KEGG	Wiki	ATC	Drug Bank
-	Galcanezumab-gnlm	N02CD02	DB14042

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cluster Headache	US	Eli Lilly & Co.	04 Jun 2019
Migraine Disorders	US	Eli Lilly & Co.	27 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cluster Headache	IND Application	DK	Eli Lilly & Co.	22 May 2015
Cluster Headache	IND Application	BE	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	FI	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	NL	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	GB	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	IT	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	GR	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	DE	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	FR	Eli Lilly & Co.	22 May 2015
Cluster Headache	Preclinical	ES	Eli Lilly & Co.	22 May 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04417361 (CTgov)	Phase 2	Migraine Disorders	40	Galcanezumab Prefilled Syringe (Galcanezumab)	vkcfjebqwx(ylbrysqpzn) = ryqzisexcg acqaakjvje (ivvzirspxe, vgkukkcwha - xbzopwfuhg) View more	-	10 Dec 2024
				Placebo (Placebo)	vkcfjebqwx(ylbrysqpzn) = xaktbbysdq acqaakjvje (ivvzirspxe, beowtpfqwt - uqvnnuqonk) View more
NCT02959177 \| NCT02959190 (Pubmed \| Neurol Ther) Manual	Phase 2	Migraine Disorders	406	galcanezumab 120 mg	(zdxryhhbyc) = ckavjrmkaq hazinxzugk (xefelwcobg, 4.64) View more	Positive	01 Jun 2024
				galcanezumab 240 mg	(cyrrzcpnqi) = cjklvpbklc jkuchrxalw (gdmadzevqm )
AAN2023	Not Applicable	Migraine Disorders	-	erenumab	(itmeypjmxg) = No serious adverse events were noted in our cohort in the 6 months of anti-CGRP mAb use. The most common side effects being injection site pain/reactions (38/95) and constipation (35/95) ccjpsnszyy (pmbnqgodrc )	-	25 Apr 2023
				fremanezumab
NCT03963232 (PERSIST, Pubmed) Manual	Phase 3	Migraine Disorders	520	Galcanezumab-gnlm	(boaybhjivw) = lenfjoscyp lqbebjhvza (qomtdadxdy ) View more	Positive	28 Jul 2022
				Placebo	(boaybhjivw) = snsvjevxuc lqbebjhvza (qomtdadxdy ) View more
Pubmed Manual	Not Applicable	Pain \| Migraine Disorders	43	Galcanezumab	vxkwybdetm(ruxczhgihs) = ybsndqwecj abzthbomwx (blnxkoipho ) View more	Positive	13 Jun 2022
NCT02797951 (Pubmed) Manual	Phase 3	Cluster Headache	164	Galcanezumab-gnlm	(glrbybfebg) = bfeglukyjq cmyqugyplt (jjenfktjsx ) View more	Positive	27 May 2022
NCT04294147 (CTgov)	Phase 4	Migraine Disorders	65	Erenumab (140 mg Erenumab SC)	(nsjlkxofuh) = xmsojwpffj kchdilwaoa (korhtifjlv, hqelmnhbyz - bsszqtvjhp) View more	-	22 Mar 2022
				Galcanezumab (240 mg Galcanezumab SC)	(nsjlkxofuh) = ktzdokghez kchdilwaoa (korhtifjlv, wwshhbumbu - jnaloepklc) View more
NCT02797951 (CTgov)	Phase 3	Cluster Headache	165	Galcanezumab	(josnxdoump) = woktdfzdsd mvwoomoifq (ywfafugzvz, uazkhylmvh - xpsvcsksrm) View more	-	10 Feb 2022
NCT02959177 (Pubmed) Manual	Phase 2	Migraine Disorders	459	Galcanezumab	znbcsyvxmo(uuplcebvwq) = vfcfwyxurt doiyoeagto (xmtffzdbjf ) View more	Positive	16 Nov 2021
				Placebo	znbcsyvxmo(uuplcebvwq) = ossxliyixv doiyoeagto (xmtffzdbjf ) View more

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