Fasinumab

Overview

Fasinumab is a human IgG1k monoclonal antibody targeted against nerve growth factor (NGF). It is currently under investigation for the treatment osteoarthritic pain and has demonstrated significantly greater pain relief and functional improvement as compared to standard therapy (i.e. NSAIDs and/or opioids) in this patient population. NGF was first discovered in the 1950s and was the first neurotrophic factor to be identified and biochemically characterized. It has since been recognized for its role in nociceptive signaling transduction and has thus become an attractive target in the treatment of chronic pain conditions.

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip	2019/05/14	NCT03949673	Phase 2	Terminated	Regeneron Pharmaceuticals
Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee	2018/10/02	NCT03691974	Phase 2	Completed	Regeneron Pharmaceuticals
To Assess the Patients' Ability to Self-Administer Fasinumab	2018/04/09	NCT03491904	Phase 1	Completed	Regeneron Pharmaceuticals
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip	2017/10/09	NCT03304379	Phase 3	Completed	Regeneron Pharmaceuticals
Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee	2017/09/18	NCT03285646	Phase 3	Terminated	Regeneron Pharmaceuticals
Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain	2017/08/10	NCT03245008	Phase 2	Completed	Mitsubishi Tanabe Pharma Corporation
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip	2017/05/19	NCT03161093	Phase 3	Completed	Regeneron Pharmaceuticals
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip	2016/02/17	NCT02683239	Phase 3	Completed	Regeneron Pharmaceuticals
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain	2015/12/02	NCT02620020	Phase 2	Completed	Regeneron Pharmaceuticals
Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects	2015/08/06	NCT02516618	Phase 1	Completed	Regeneron Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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