Skip to main content

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Development Status: NDA Withdrawn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

DateArticle
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer