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NKTR-181 Approval Status

FDA Approved: No
Brand name: NKTR-181
Generic name: loxicodegol
Company: Nektar Therapeutics
Treatment for: Pain

NKTR-181 (loxicodegol) 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 Status and FDA Approval Process for NKTR-181

DateArticle
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
Sep 27, 2013Nektar Phase II Trial for NKTR-181 Misses Primary Endpoint
Jun 19, 2013Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181
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
Feb 27, 2012Nektar Presents Positive Proof-of-Concept Clinical Data for Its New Opioid Molecule, NKTR-181, at American Academy of Pain Medicine's 28th Annual Meeting
Sep 22, 2011Nektar Presents Positive Data for Novel Opioid Analgesic, NKTR-181, at the 2011 American Academy of Pain Management Annual Meeting
Jun  7, 2011Data from Phase 1 Study of NKTR-181 Demonstrate Proof-of-Concept for Nektar's Novel Opioid Analgesic Candidate
Oct 20, 2010Nektar Presents New Preclinical Data on NKTR-181 at Anesthesiology 2010

Further information

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