A randomized placebo-controlled double-blind phase III two-arm study to investigate the reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with combination of CGRP mAbs and onabotulinumtoxin A intramuscularly compared with CGRP mAbs and placebo in male and female participants with chronic migraine aged 18-70 years.

Start Date06 Jun 2025

Sponsor / Collaborator-

NCT06237062

/ TerminatedNot Applicable

Real-world Experience of Patients Newly Started on Erenumab in the Gulf Region: a Longitudinal Prospective Observational Study

The objective of this study was to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients who newly started on erenumab over 12 weeks

Start Date05 Jun 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06212661

/ Enrolling by invitationNot ApplicableIIT

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Start Date05 Apr 2024

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Erenumab (Genetical Recombination)

100 Translational Medicine associated with Erenumab (Genetical Recombination)

100 Patents (Medical) associated with Erenumab (Genetical Recombination)

624

Literatures (Medical) associated with Erenumab (Genetical Recombination)

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-Clinical Practice

Effect of Erenumab on Patient-Reported Outcomes in Episodic Migraine in Asia, the Middle East, and Latin America

Article

Author: Tai, Mei-Ling Sharon ; Zhao, Yi Jing ; Wen, Shihua ; Su, Wendy ; Saravia, Bibiana ; Roxas, Artemio A. ; Kim, Byung Kun ; Tran, Tai Ngoc ; Chowdhury, Debashish ; Mondal, Subhayan ; Riachi, Naji J. ; Tanprawate, Surat ; Arkuszewski, Michal ; Wang, Shuu-Jiun ; Ecochard, Laurent

Background and Objectives:

Migraine is a significant disabling neurologic headache disorder globally. Evaluating patient-related outcomes (PROs) is necessary to assess the impact of therapeutic interventions in preventive therapy. An exploratory analysis of data from the EMPOwER study examined the effect of erenumab on PROs in patients with episodic migraine (EM) in regions underrepresented in the pivotal Phase 3 trials of erenumab, specifically Asia, the Middle East, and Latin America.

Methods:

Patients (N = 900) were randomized (2:3:3) to receive monthly subcutaneous injections of erenumab 140 mg, erenumab 70 mg, or placebo. Adjusted mean changes from baseline in the Headache Impact Test (HIT-6), Migraine Physical Function Impact Diary (MPFID), modified Migraine Disability Assessment (mMIDAS), and EuroQoL 5-dimension 5-level scale (EQ-5D-5L) scores were assessed during the double-blind treatment phase of 3 months.

Results:

A statistically significant reduction from baseline in the HIT-6 total score was observed for erenumab 140 mg (-9.34, p < 0.001) and 70 mg (-8.39, p = 0.004) vs placebo (-6.62) at Month 3. Improvement in MPFID scores was also greater in the erenumab groups vs the placebo group (Everyday Activity: 140 mg, -5.61 [p = 0.002]; 70 mg, -4.94 [p = 0.011]; placebo, -3.19; Physical Impairment: 140 mg, -4.27 [p = 0.014]; 70 mg, -3.95 [p = 0.021]; placebo, -2.31) at Month 3. Similar findings were observed for mMIDAS scores (140 mg -8.99 [p < 0.001], 70 mg -8.11 [p = 0.011] vs placebo [-6.59]) and the EQ-5D-5L quality-of-life visual analog scale scores (140 mg 8.13 [p = 0.017], 70 mg 7.08 [p = 0.088] vs placebo [5.22]), although no meaningful between-group difference was noted for index values.

Discussion:

Erenumab showed favorable effects on PROs when compared with placebo in patients with EM. These results enhance the evidence for erenumab as an effective preventive therapy for patients with EM.

Trial Registration Information:

Clinicaltrials.gov/study/NCT03333109.

01 Mar 2026·HEADACHE

Comprehensive assessment of erenumab efficacy in participants with high‐frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study

Article

Author: Dodick, David W. ; Paiva da Silva Lima, Gabriel ; Chou, Denise E. ; Chehrenama, Mahan ; Zhu, Yineng ; Khodavirdi, Ani C. ; Rao, Renata ; Szklener, Sebastian ; Nastaj, Marcin ; Szabó, Gyöngyi ; Tassorelli, Cristina ; Bhatia, Ajay K.

Abstract:

Objective:

To evaluate the effect of erenumab treatment beyond monthly migraine days in patients with high‐frequency episodic migraine who did not respond to at least one previous migraine preventive treatment.

Background:

Reduction in monthly migraine days has been the efficacy standard for migraine preventive treatments; however, it does not fully capture the holistic benefit of the therapy. Erenumab, a monoclonal antibody targeting the calcitonin gene–related peptide pathway, has demonstrated reduction in monthly migraine days and improvement in function in patients with episodic and chronic migraine.

Methods:

In this phase 4, interventional, double‐blind, randomized, placebo‐controlled, multicenter, global study, treatment with erenumab was assessed over 4 months in adults with high‐frequency episodic migraine. The study was conducted at 61 sites located across North America and Europe between September 2020 and October 2023. Patients with ≥1 qualifying oral triptan‐treated migraine attack at baseline were randomized to receive erenumab 140 mg or placebo subcutaneously once monthly. The primary endpoint was change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3; secondary endpoints included change from baseline in mean monthly function, mean monthly duration of at least moderate pain intensity in migraine attacks, and mean monthly peak migraine pain intensity. Safety outcomes were also assessed.

Results:

Of 512 randomized patients, 510 received erenumab 140 mg ( n = 254) or placebo ( n = 256) once monthly. Demographics and baseline characteristics were balanced between the two treatment arms. Erenumab 140 mg was superior to placebo in reducing duration of moderate or severe headache pain intensity over months 1, 2, and 3 (least squares mean [95% confidence interval {CI}] difference, −7.95 [−11.45, −4.46]; p < 0.001). Compared with placebo, erenumab significantly reduced migraine functional impact as assessed by the four domains of the Migraine Functional Impact Questionnaire, with a least squares mean (95% CI) difference of −7.36 (−10.80, −3.92) for physical functioning, −7.10 (−10.34, −3.87) for usual activities, −6.82 (−10.37, −3.27) for social functioning, and − 7.05 (−10.76, −3.34) for emotional functioning ( p < 0.001 for all domains). Significant reductions with erenumab compared with placebo were also observed in duration of at least moderate pain intensity in residual or break‐through migraine attacks (least squares mean [95% CI] difference, −1.07 [−1.92, −0.22]; p = 0.013) and peak migraine pain intensity (−0.48 [−0.85, −0.11]; p = 0.011). Incidence of grade 3 adverse events was 1.6% with erenumab and 1.2% with placebo; no grade 4 or fatal adverse events were reported in either treatment arm.

Conclusion:

Findings from the EMBRACE study demonstrated that treatment with erenumab in patients with high‐frequency episodic migraine can provide positive therapeutic effects on ictal burden and pain, with residual migraine attacks tending to be shorter and less painful, with less overall impact.

News (Medical) associated with Erenumab (Genetical Recombination)

26 Mar 2026

·www.globenewswire.com

Tonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) to Assess Potential for Treating Migraine and Craniofacial Pain

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia TNX-1900 will be studied in the trigeminal neurovascular reactivity model, by measuring the forehead skin blood flow response to capsaicin and electrical stimulation by Laser Speckle Contrast Imaging (LSCI) Oxytocin treatment affects a pathway distinct from the recently available CGRP migraine treatment drug class BERKELEY HEIGHTS, N.J., March 26, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced that the first participant has been dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on trigeminal nerve-mediated vasodilation of the forehead using capsaicin as well as electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, is serving as principal investigator and sponsor for the study in a collaborative research agreement with Tonix. In animal studies, intranasal oxytocin has been shown to bind to oxytocin receptors in the trigeminal ganglion, blocking the release of calcitonin gene-related peptide (CGRP), a potent vasodilator critically involved in the pathogenesis of migraine.1 Dr. Maassen van den Brink has previously found a CGRP inhibitor and a triptan to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.2,3 “We are excited to collaborate with Professor Maassen van den Brink on this proof-of-concept study investigating the potential for TNX-1900 for treating migraine, craniofacial pain, and other related conditions,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “While there are several CGRP inhibitors approved for the treatment of migraine, TNX-1900’s oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non-opioid treatment for migraine and other craniofacial pain conditions.” As part of the preliminary work in support of this study, Dr. Maassen van den Brink’s team recently validated a newer detection method for dermal blood flow known as Laser Speckle Contrast Imaging (LSCI) in the trigeminal neurovascular reactivity model.4 “We are excited to be using LSCI in this study of TNX-1900, which adds to our established model by providing real-time and higher resolution dermal blood flow measurements, compared to Laser Doppler Perfusion Imaging used in earlier studies,” said Dr. Maassen van den Brink. “Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes.” About Migraine Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.5 Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.6 In the U.S., approximately 39 million Americans suffer from migraines, and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).6 About TNX-1900 TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for the treatment of migraine and craniofacial pain. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system7 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.1 Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. The addition of magnesium to the oxytocin formulation in TNX-1900 enhances oxytocin receptor binding8 as well as having an inhibitory effect on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.9 Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children.10 Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies.11 For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. This mechanism is being investigated in a Phase 1 study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead model for craniofacial pain. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to craniofacial pain conditions, TNX-1900 is being developed for treatment of binge eating disorder, adolescent obesity, bone health in pediatric autism and arginine-vasopressin deficiency. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions. Citations 1Tzabazis A, et al. Oxytocin receptor: Expression in the trigeminal nociceptive system and potential role in the treatment of headache disorders. Cephalalgia. 2016. 36(10):943-50.2de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.3Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.4van Lohuizen et al. 2025. Trigeminovascular activity using a forehead dermal blood flow model: preliminary results of a validation study. J Headache and Pain 26 (Suppl 2): 138.5The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.6Burch et al. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin 37 (2019):631–649.7Yeomans DC, et al. Nasal oxytocin for the treatment of psychiatric disorders and pain: achieving meaningful brain concentrations. Transl Psychiatry. 2021. 11(1):388.8Antoni FA and Chadio SE. Essential role of magnesium in oxytocin-receptor affinity and ligand specificity. Biochem J. 1989. 257(2):611-4.9Cai Q, et al. Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Psychiatry Clin Neurosci. 2018. 72(3):140-151.10Yeomans, DC et al. 2017. US patent US2017368095.11MaassenVanDenBrink A, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016. 37(9):779-788. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including long-acting human monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X. *Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor ContactsJessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862) 799-8599 Brian Korbastr partners(917) 653-5122brian.korb@astrpartners.com Media ContactsDeborah ElsonTonix Pharmaceuticalsdeborah.elson@tonixpharmaceuticals.com Ray JordanPutnam Insightsray@putnaminsights.com

Phase 1Phase 2

17 Mar 2026

·firstwordpharma.com

Biopharma bites: A trio of drugs join TrumpRx, BioMarin stops several studies, plus paediatric proof for Lilly's Ebglyss

Drugs from Amgen, GSK join TrumpRxBioMarin stops certain skeletal studies after safety signalLilly's Ebglyss passes paediatric testDrugs from Amgen, GSK join TrumpRxTrumpRx, a direct-to-consumer (DTC) platform run by the US government, welcomed three new products to its site on Monday, according to a post on X from the White House. Amgen is offering its migraine medicine Aimovig (erenumab), as well as Amjevita (adalimumab-atto) — its biosimilar of AbbVie's Humira (adalimumab) — for a monthly cash-pay price of $299 each. GSK's Incruse Ellipta (umeclidinium), an inhaled treatment for chronic obstructive pulmonary disease (COPD), is available for $159.20 per month on TrumpRx for self-pay patients. The three additions to TrumpRx come after the website officially launched in February with price cuts for about 43 medications.Both pharmas, along with seven other drugmakers, agreed in December to sell some of their products on DTC sites as part of a most favoured nation drug pricing agreement with the Trump administration. -Elizabeth EatonBioMarin stops certain skeletal studies after safety signalBioMarin disclosed in a securities filing Monday that, following a safety signal in a pair of investigator-sponsored trials, it has halted its own Phase II studies evaluating Voxzogo (vosoritide) in patients with certain skeletal conditions. The drugmaker said that "several" cases of slipped capital femoral epiphysis (SCFE) occurred in the investigator-sponsored trials. As a result, it will discontinue dosing and enrollment in its studies involving patients with Turner syndrome, SHOX-deficiency and ACAN-deficiency. BioMarin emphasised that SCFE events have not been observed in its trials of these indications, nor in any of its achondroplasia or hypochondroplasia studies. The Phase II CANOPY trial evaluating Voxzogo in children with Noonan syndrome, as well as those living with idiopathic short stature (ISS) without ACAN-deficiency, will continue unaffected. The FDA approved Voxzogo for achondroplasia in 2021; since then, the company has made expanding the modified C-type natriuretic peptide's label into additional skeletal conditions central to its growth strategy. Before Monday's setback, BioMarin had been targeting five new indications for Voxzogo by 2031, including hypochondroplasia, ISS, Noonan syndrome, Turner syndrome and SHOX deficiency. -Elizabeth EatonLilly's Ebglyss passes paediatric testEli Lilly's Ebglyss (lebrikizumab-lbkz) met the primary and key secondary endpoints of the Phase III ADorable-1 trial in paediatric patients with moderate-to-severe atopic dermatitis. The company plans to submit the data to the FDA and other regulators for a potential update to the IL-13 inhibitor's label.Top-line results showed that 63% of patients on Ebglyss achieved meaningful skin improvement at week 16, as measured by a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline, and 44% achieved clear or almost clear skin on the Investigator's Global Assessment (IGA). For patients taking placebo, 22% achieved EASI-75 and 15% had clear or almost clear skin based on IGA."Ebglyss has already changed what's possible for adults and adolescents," said Adrienne Brown, president of Lilly Immunology. "Now, these data show Ebglyss also provided disease control in paediatric patients."The company has rights to Ebglyss in all markets, except Europe, where Almirall has licensed rights for all dermatology indications, including atopic dermatitis.-Matthew Dennis

Clinical ResultPhase 3Phase 2Drug Approval

07 Jan 2026

·pmlive.com

Amgen agrees to lower prescription drug costs in deal with US government

Amgen has announced a deal with the US government that will lower the company’s prescription drug costs for US patients while reinforcing its commitment to US innovation. As part of the agreement, Amgen’s direct-to-patient programme, AmgenNow, will be expanded to include Aimovig (erenumab) and Amjevita (adalimumab). This will lower the prices of each drug by nearly 60% and 80% respectively compared to the current US list prices. Both drugs will be available at a discounted monthly price of $299. AmgenNow was launched by the company in October 2025, reducing the price of Repatha (evolocumab) for patients in the US to $239 per month, which is almost 60% below its current US list price. The programme is open to all eligible patients, including those who are uninsured, patients enrolled in high-deductible health plans or those who choose to pay for prescription drugs with cash or out of pocket. Amgen has invested over $40bn in R&D and manufacturing in the US over the past seven years. In 2025, Amgen announced a further $2.5bn investment in US manufacturing capital investments. This included expansions of $900m in Ohio and $1bn in North Carolina. The agreement means that US pharmaceutical tariffs on the company will be delayed for three years. Robert A Bradway, chairman and CEO of Amgen, commented: “We look forward to…[seeing] that this biopharmaceutical innovation is appropriately supported globally.”

License out/inDrug ApprovalBiosimilar

100 Deals associated with Erenumab (Genetical Recombination)

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KEGG	Wiki	ATC	Drug Bank
-	Erenumab (Genetical Recombination)	N02CD01	DB14039

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Amgen, Inc.	17 May 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuralgia	Phase 2	United States	Amgen, Inc.	31 May 2022
Trigeminal Nerve Diseases	Phase 2	United States	Amgen, Inc.	31 May 2022
Trigeminal Nerve Injuries	Phase 2	United States	Amgen, Inc.	31 May 2022
Trigeminal Neuralgia	Phase 2	United States	Amgen, Inc.	31 May 2022
Temporomandibular Joint Disorders	Phase 2	United States	Amgen, Inc.	15 Nov 2021
Flushing	Phase 2	Denmark	Novartis Pharmaceuticals Corp.	09 Jun 2020
Rosacea	Phase 2	Denmark	Novartis Pharmaceuticals Corp.	09 Jun 2020
Headache	Phase 2	Denmark	Amgen, Inc.	05 Apr 2019
Headache	Phase 2	Denmark	Novartis AG	05 Apr 2019
Post-Concussion Syndrome	Phase 2	Denmark	Novartis AG	05 Apr 2019

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04603976 (REFORM, Pubmed \| Eur J Neurol)	Phase 4	Migraine Disorders	582	Erenumab 140 mg	bxuqfiglul(fqvqhfifxr) = For HIT-6, optimal thresholds included an 8-point reduction (53% sensitivity, 84% specificity) or a 12% relative reduction (54% sensitivity, 84% specificity). ogivmnomef (dxdgmwieal ) View more	Negative	01 Apr 2026
NCT03333109 (EMPOwER, Pubmed \| Neurol Clin Pract)	Phase 3	Migraine Disorders	900	Erenumab 140 mg	iunqflbfkl(abtplxhsjq) = wodjcbgnap izhuohazqg (hrahcutxqx ) View more	Positive	01 Apr 2026
				Erenumab 70 mg	iunqflbfkl(abtplxhsjq) = ehbjwomtut izhuohazqg (hrahcutxqx ) View more
NCT04252742 (EMBRACE, Pubmed \| Headache)	Phase 4	-	510	Erenumab 140 mg	retmsqklwu(xotqqtknvm) = Compared with placebo, erenumab significantly reduced migraine functional impact as assessed by the four domains of the Migraine Functional Impact Questionnaire, with a least squares mean (95% CI) difference of −7.36 (−10.80, −3.92) for physical functioning, −7.10 (−10.34, −3.87) for usual activities, −6.82 (−10.37, −3.27) for social functioning, and − 7.05 (−10.76, −3.34) for emotional functioning ( p < 0.001 for all domains). gzajrrmntr (heuppfatwo )	Positive	01 Mar 2026
				Placebo
NCT04098250 (CTgov)	Phase 2	Post-Traumatic Headache	6	Erenumab (Erenumab)	llazhrzzgz(jcdnrudwkd) = lckupsmiid ippfcimbyc (ropaweaxaj, 2.8) View more	-	23 Oct 2025
				Placebo (Placebo)	llazhrzzgz(jcdnrudwkd) = jtnejdgaag ippfcimbyc (ropaweaxaj, 6.0) View more
NCT04884763 (CTgov)	Phase 2	Temporomandibular Joint Disorders	30	Erenumab-aooe (Arm A)	xoxjihduha(raumpbjwfb) = gqkcrbfidm qiyrsdrtgx (ppkolyiueb, agvmuviogn - sozjhtqdiy) View more	-	19 Aug 2025
				Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments (Arm B)	xoxjihduha(raumpbjwfb) = hdbdeyvras qiyrsdrtgx (ppkolyiueb, diqmzvgxoq - spygkxjigm) View more
NCT03971071 (Pubmed \| Eur J Neurol)	Phase 4	Headache Disorders, Secondary	552	Erenumab 70 mg	lfdargetxe(lpeqpfufvh) = No new safety concerns were identified (grade ≥ 3, 35 [6.3%]; serious, 17 [3.1%]; adverse events leading to treatment discontinuation, 5 [0.9%]) flebgqeage (mmldeanfbz )	Positive	01 Aug 2025
				Erenumab 140 mg
NCT04970355 (CHERUB01, Pubmed \| JAMA Netw Open)	Phase 2	Cluster Headache CGRP	81	Erenumab	tyonqqjfai(ehmimdrbdi) = tmqfgrzwal esvenjvzgk (kjzakcczxv )	Negative	17 Jun 2025
				Placebo	tyonqqjfai(ehmimdrbdi) = hwqbiyhlru esvenjvzgk (kjzakcczxv )
NCT04674020 \| NCT04603976 (REFORM study, Pubmed \| J Headache Pain)	Phase 4	Migraine Disorders soluble urokinase-plasminogen activator receptor (suPAR)	623	Erenumab 140 mg	hmffxbltxf(semikqsufb): P-Value = 0.005	Negative	24 Apr 2025
				erenumab (Healthy Controls)
NCT04084314 (APOLLON, Pubmed \| J Headache Pain) Manual	Phase 4	Migraine Disorders	701	Erenumab 70 mg	ivvpijrovy(abecffevci) = 4.1% of total cohort discontinued erenumab treatment during open-label treatment phase. Out of these, 65.5% (N = 19) were considered treatment-related. rytackreop (akpvonqgoo )	Positive	25 Sep 2024
				Erenumab 140 mg
NCT04825678 (CTgov)	Phase 4	Migraine Disorders	240	Erenumab (Erenumab QM: Continued SoC)	bfncngbmgc(vbcigdglin) = xveqqzijuj oqtvifoejx (hqdhqsmuei, 32.48) View more	-	19 Sep 2024
				Erenumab (Erenumab QM: Discontinued SoC)	bfncngbmgc(vbcigdglin) = vwuqsdfyvf oqtvifoejx (hqdhqsmuei, 57.66) View more

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Deal

Boost your decision using our deal data.

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis