Drugs / Erenumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | AIMOVIG | — | 2019-03-11 – 2022-10-03 | fda.gov ↗ |
| Approved | EU (EMA) | Aimovig | — | 2018-07-26 | europa.eu ↗ |
| Approved | US (FDA) | AIMOVIG | — | 2018-05-17 | fda.gov ↗ |
Trials 48 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT04920331 | Sep 2021 → Feb 2022 | migraine disorder | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 1 | NCT04179474 | Sep → Dec 2019 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT03499119 | May 2018 → Nov 2021 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02741310 | Feb → Aug 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02792517 | Feb → Sep 2016 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02542605 | Nov 2015 → Sep 2017 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01890109 | May 2013 → Mar 2014 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01723514 | Nov 2012 → Jul 2014 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01688739 | Mar 2012 → Mar 2013 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT05684692 | Aug 2023 → Nov 2026 expected | chronic pain syndrome, schwannomatosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05049057 | Jul 2022 → May 2026 overdue | traumatic brain injury, traumatic encephalopathy | Henry M. Jackson Foundation for the Advancement of Military Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04970355 | Dec 2021 → Sep 2023 | cluster headache syndrome | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT04303845 | Aug 2021 → Apr 2022 | hemicrania continua | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT04098250 | Jan 2021 → Jan 2024 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04419259 | Jun 2020 → Mar 2021 | rosacea | Messoud Ashina | Unknown | No outcome recorded |
| Phase 2 | NCT03974360 | Apr → Dec 2019 | traumatic brain injury, traumatic encephalopathy | Danish Headache Center | Completed | No outcome recorded |
| Phase 2 | NCT02630459 | Jan 2016 → Sep 2017 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02575833 | Nov 2015 → Jan 2017 | coronary artery disorder | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02174861 | Jun 2014 → May 2017 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02066415 | Mar 2014 → Feb 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01952574 | Aug 2013 → Sep 2014 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT06411067 | Feb 2020 → May 2022 | fibromyalgia | United States Naval Medical Center, Portsmouth | Withdrawn | No outcome recorded |
| Phase 3 | NCT04114630 | Oct 2019 → Dec 2021 | migraine disorder | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT03832998 | Sep 2019 → Jan 2025 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03867201 | Aug 2019 → Aug 2021 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03836040 | Jul 2019 → Nov 2025 overdue | migraine disorder | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03812224 | Apr 2019 → Mar 2020 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03333109 | Feb 2018 → Jan 2020 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03096834 | Mar 2017 → Jan 2018 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02483585 | Jul 2015 → Jul 2016 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02456740 | Jul 2015 → Sep 2016 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07655440 | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05284019 | Mar 2022 → Feb 2023 | migraine disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 4 | NCT04825678 | Jun 2021 → Sep 2023 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04265755 | Oct 2020 → Jan 2023 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04465357 | Oct 2020 → Jun 2022 | migraine disorder | Merle Diamond | Completed | No outcome recorded |
| Phase 4 | NCT04674020 | Oct 2020 → Jul 2025 | migraine disorder | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04592952 | Oct 2020 → Aug 2025 | migraine disorder | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04603976 | Sep 2020 → Oct 2022 | migraine disorder | Danish Headache Center | Unknown | No outcome recorded |
| Phase 4 | NCT04252742 | Sep 2020 → Oct 2023 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03912337 | Dec 2019 → Jul 2021 | migraine disorder | Amgen | Terminated | No outcome recorded |
| Phase 4 | NCT04084314 | Sep 2019 → Feb 2023 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03977649 | Jul 2019 → Jul 2021 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03927144 | May 2019 → Oct 2021 | migraine disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03773562 | Mar 2019 → Jun 2022 | migraine disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03828539 | Feb 2019 → Jul 2020 | migraine disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04659226 | Jul 2021 → Dec 2022 | migraine disorder | University of L'Aquila | Completed | No outcome recorded |
| — | NCT04452929 | Jul 2020 → Feb 2022 | migraine with aura, migraine without aura | Danish Headache Center | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT05142228 Comparator | May → Oct 2022 | cranial nerve neuropathy | University of Maryland, Baltimore | Terminated | No outcome recorded |
| Phase 2 | NCT05162027 Comparator | May 2022 → Jan 2023 | temporomandibular joint disorder | University of Maryland, Baltimore | Terminated | No outcome recorded |
| Phase 2 | NCT04884763 Comparator | Nov 2021 → Jan 2024 | temporomandibular joint disorder | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT04054024 Comparator | Oct 2019 → Oct 2021 | trigeminal neuralgia | Danish Headache Center | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04249427 Comparator | Feb 2021 → Jul 2023 | persistent idiopathic facial pain, sinusitis | David Jang, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT04294147 Comparator | Oct 2020 → Mar 2021 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT03971071 Comparator | Oct 2019 → Dec 2022 | migraine disorder | Amgen | Completed | No outcome recorded |
Press releases naming this drug 44 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-11-08 | Novartis Pharmaceuticals | Novartis announces new publication in Cephalalgia of data showcasing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗ |
| 2021-11-08 | Amgen | First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia amgen.com ↗ |
| 2021-06-23 | Amgen | Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults amgen.com ↗ |
| 2020-11-02 | Novartis Pharmaceuticals | Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention novartis.com ↗ |
| 2020-10-03 | Amgen | Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig® (erenumab-aooe) In Adult Patients With Episodic Migraine amgen.com ↗ |
| 2020-04-16 | Novartis Pharmaceuticals | Novartis announces data in Neurology reinforcing the real-world and long-term effectiveness and safety of Aimovig® as a preventive treatment across the full spectrum of migraine novartis.com ↗ |
| 2019-09-09 | Novartis Pharmaceuticals | Novartis data confirm long-term efficacy and safety of Aimovig® for majority of patients with episodic migraine novartis.com ↗ |
| 2019-07-01 | Novartis Pharmaceuticals | Novartis data underpin long-term efficacy of Aimovig® where other treatments have failed novartis.com ↗ |
| 2019-07-01 | Novartis Pharmaceuticals | Novartis data show Aimovig® cuts acute migraine medication days by half in patients who failed prior preventive therapies novartis.com ↗ |
| 2019-05-02 | Novartis Pharmaceuticals | Novartis to highlight extensive long-term safety and efficacy data of Aimovig® across the spectrum of migraine at AAN novartis.com ↗ |
| 2019-05-02 | Amgen | Amgen To Highlight Extensive Long-Term Safety And Efficacy Data Of Aimovig® (erenumab-aooe) Across The Spectrum Of Migraine At AAN Annual Meeting amgen.com ↗ |
| 2018-10-23 | Novartis Pharmaceuticals | Novartis announces Lancet publication of pioneering study in migraine prevention showing efficacy of Aimovig® where other treatments have failed novartis.com ↗ |
| 2018-07-30 | Novartis Pharmaceuticals | Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its-kind treatment specifically designed for migraine prevention novartis.com ↗ |
| 2018-06-28 | Novartis Pharmaceuticals | Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig® (erenumab) in patients with chronic and episodic migraine novartis.com ↗ |
| 2018-06-28 | Amgen | Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig™ (erenumab-aooe) In Patients With Chronic And Episodic Migraine amgen.com ↗ |
| 2018-06-01 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Aimovig® (erenumab) for the prevention of migraine novartis.com ↗ |
| 2018-05-18 | Novartis Pharmaceuticals | Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention novartis.com ↗ |
| 2018-05-17 | Amgen | FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention amgen.com ↗ |
| 2018-04-17 | Novartis Pharmaceuticals | Novartis presents first-of-its-kind evidence at AAN reinforcing robust and consistent efficacy of AimovigTM* (erenumab) for migraine patients with multiple treatment failures novartis.com ↗ |
| 2018-04-17 | Amgen | Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures amgen.com ↗ |
| 2018-01-22 | Novartis Pharmaceuticals | Novartis reports erenumab met all primary and secondary endpoints in unique Phase IIIb study in episodic migraine patients who have failed multiple prior preventive treatments novartis.com ↗ |
| 2018-01-22 | Amgen | Amgen Reports Aimovig™ (Erenumab) Met All Primary And Secondary Endpoints In Unique Phase 3b Study In Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments amgen.com ↗ |
| 2017-11-29 | Novartis Pharmaceuticals | Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab (AMG334) in migraine prevention novartis.com ↗ |
| 2017-11-29 | Amgen | Aimovig™ (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention amgen.com ↗ |
| 2017-09-07 | Novartis Pharmaceuticals | Novartis presents new analysis demonstrating AMG 334 (erenumab) significantly reduced monthly migraine days in patients who failed previous preventive therapies novartis.com ↗ |
| 2017-09-07 | Amgen | New Data Demonstrate Aimovig™ (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies amgen.com ↗ |
| 2017-07-20 | Amgen | FDA Accepts Biologics License Application For Aimovig™ (erenumab) amgen.com ↗ |
| 2017-06-21 | Novartis Pharmaceuticals | Novartis achieves important regulatory milestone for AMG 334 (erenumab) in migraine prevention with EMA filing acceptance novartis.com ↗ |
| 2017-06-08 | Novartis Pharmaceuticals | Novartis presents data demonstrating efficacy of AMG 334 (erenumab) in migraine prevention at the American Headache Society Annual Meeting novartis.com ↗ |
| 2017-06-08 | Amgen | Amgen Presents Erenumab Data At The 59th Annual Scientific Meeting of the American Headache Society amgen.com ↗ |
| 2017-05-18 | Amgen | Amgen Submits Biologics License Application To The FDA For Erenumab amgen.com ↗ |
| 2017-04-24 | Novartis Pharmaceuticals | Novartis expands global collaboration with Amgen to commercialize first-in-class AMG 334 (erenumab) program in migraine prevention in the US and Canada novartis.com ↗ |
| 2017-04-24 | Amgen | Amgen Announces Expanded Commercial Collaboration With Novartis For Erenumab In Migraine amgen.com ↗ |
| 2016-11-16 | Novartis Pharmaceuticals | Novartis announces AMG 334 significantly reduces monthly migraine days in second pivotal Phase III episodic migraine study novartis.com ↗ |
| 2016-11-16 | Amgen | Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study amgen.com ↗ |
| 2016-09-28 | Novartis Pharmaceuticals | Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine novartis.com ↗ |
| 2016-09-28 | Amgen | Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In First Phase 3 Study amgen.com ↗ |
| 2016-09-15 | Novartis Pharmaceuticals | Novartis presents new positive data at EHMTIC showing AMG 334 significantly reduces monthly migraine days in chronic migraine novartis.com ↗ |
| 2016-09-15 | Amgen | Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine amgen.com ↗ |
| 2016-06-08 | Novartis Pharmaceuticals | Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention novartis.com ↗ |
| 2016-06-08 | Amgen | Amgen Announces Erenumab (AMG 334) Significantly Reduces Patients' Monthly Migraine Days In Phase 2 Study For The Prevention Of Chronic Migraine amgen.com ↗ |
| 2015-06-19 | Amgen | Amgen Presents Open-Label Extension Data From Ongoing Phase 2 Study Of AMG 334 In The Prevention Of Episodic Migraine amgen.com ↗ |
| 2015-05-15 | Amgen | Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine amgen.com ↗ |
| 2015-05-11 | Amgen | Amgen To Present AMG 334 Data At 17th Congress of the International Headache Society amgen.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Erenumab | “Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug.” NCT04659226 ↗45“Erenumab is a novel CGRP-receptor antibody with preventive efficacy in migraine.” PMID 30360965 ↗ Oct 2018 |
| Known as | Aimovig | “Erenumab-Aooe 140 MG/ML [Aimovig]” NCT04465357 ↗ |
| Known as | AMG 334 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04419259 ↗ |
| Known as | AMG 334, Aimovig | “AMG 334, Aimovig™” NCT02630459 ↗ |
| Known as | Erenumab-aooe | “Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects.” NCT03912337 ↗ |
| Action | Inhibit | “Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention” PMID 31852816 ↗ Dec 20191“Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3833329 ↗ |
| Modality | Monoclonal antibody | “a fully human monoclonal antibody” PMID 35978286 ↗ Aug 2022 |
| Route | Subcutaneous | “Administered by subcutaneous injection” NCT01688739 ↗ |
| Target | CALCRL | “Calcitonin gene-related peptide type 1 receptor antagonist” CHEMBL3833329 ↗ |