fremanezumab

Trade name: Ajovy

mAbapproved

Approved

Sep 14, 2018

Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines. It is given by subcutaneous injection. — Wikipedia

Clinical trial activity

32 trials · 11 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
19
Phase 3
15
Phase 4
7

Earliest trial started Oct 1, 2013 (NCT01991509)

Timeline

2010s

  1. Jan 1, 2013

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Teva — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2016

    Teva — Earliest Phase 3 Sponsor(trial)

  4. Sep 14, 2018

    Teva — Earliest FDA Approval

  5. Sep 14, 2018

    Teva — Marketing Organization

  6. Sep 14, 2018

    Teva — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 14, 2018

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • fremanezumab
  • fremanezumab-vfrm
  • lbr-101
  • tev-48125

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06173661Phase 4Jan 31, 2024Harvard University, Teva
NCT06244823Phase 4Mar 1, 2023Sanidad de Castilla y Leon, University of Valladolid
NCT05724771Phase 4Jan 26, 2023Chicago Headache Center
NCT05458011Phase 3Aug 23, 2022Teva
NCT05284019Phase 4Mar 4, 2022Lundbeck
NCT04693533Phase 4Aug 1, 2021Harvard University, Teva
NCT04334408Phase 2Jan 31, 2021Mayo Clinic
NCT04461795Phase 4Dec 1, 2020Clinvest
NCT04447729Phase 2Oct 15, 2020Teva
NCT04530110Phase 3Sep 16, 2020Teva
NCT04547179N/ASep 15, 2020Manhattan Beach Orthodontics
NCT04464707Phase 3Jul 30, 2020Teva
NCT04458857Phase 3Jul 16, 2020Teva
NCT04355117Phase 3May 31, 2020Otsuka
NCT04041284Phase 4Aug 10, 2019Teva
NCT03965091Phase 2May 31, 2019Teva
NCT03303105Phase 3Jan 4, 2018Otsuka
NCT03303092Phase 2/Phase 3 (Phase 3)Dec 19, 2017Otsuka
NCT03303079Phase 2/Phase 3 (Phase 3)Dec 19, 2017Otsuka
NCT03347188Phase 2Nov 17, 2017Teva
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TevaFor profit222052013
OtsukaFor profit4412017
Harvard UniversityAcademic/Hospital2212021
Chicago Headache CenterAcademic/Hospital1112023
ClinvestFor profit1112020
LundbeckFor profit1112022
Manhattan Beach OrthodonticsAcademic/Hospital1112020
Mayo ClinicAcademic/Hospital1112021
NCGS, Inc.For profit1012014
Sanidad de Castilla y LeonAcademic/Hospital1012023
University of ValladolidAcademic/Hospital1112023
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
TevaFor profitMKTGSep 14, 2018
TevaFor profitNDASep 14, 2018