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NKTR-181 FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 20, 2020.

FDA Approved: No (Discontinued)
Brand name: NKTR-181
Generic name: oxycodegol
Company: Nektar Therapeutics
Treatment for: Pain

Development Status: NDA Withdrawn

NKTR-181 (oxycodegol) is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain thus reducing abuse potential and CNS-mediated side effects. NKTR-181 is in development for the treatment of chronic low back pain in adult patients new to opioid therapy.

Development timeline for NKTR-181

Jan 14, 2020Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol
Jul 30, 2018Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
May 31, 2018Nektar Therapeutics Announces Submission of a New Drug Application to the U.S. FDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy
Jul 18, 2017Nektar Announces Topline Data from Human Abuse Potential Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain
Jun  7, 2012Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain

Further information

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