Drugs / OXYCODEGOL
OXYCODEGOL
also known as
NKTR-181 · Loxicodegol · NKTR-181 phosphate · Oxicodegol · Oxicodegol phosphate · OXYCODEGOL PHOSPHATE
Small molecule targets OPRM1 via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic pain syndrome | 2018-05-31 | “today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for NKTR-181” nektar.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03802227 | Oct 2018 → Dec 2019 | — | Nektar Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT01619839 | Jun 2012 → Aug 2013 | osteoarthritis, knee | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT02367820 | Apr 2015 → Dec 2017 | chronic pain syndrome | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02362672 | Mar 2015 → Dec 2016 | chronic pain syndrome | Nektar Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2020-01-14 | Nektar Therapeutics | Regulatory Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol nektar.com ↗
As a result of today's vote at the meeting, the Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program. |
| 2018-07-30 | Nektar Therapeutics | Regulatory Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA nektar.com ↗ |
| 2018-06-14 | Nektar Therapeutics | Results New Data for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy, Presented at College on Problems of Drug Dependence 80th Annual Scientific Meeting nektar.com ↗
The data presented show that NKTR-181 demonstrates consistently low abuse potential when we look at a range of measurements used to understand potential abuse liability of investigational medicines including the MADDERS assessment. |
| 2018-05-31 | Nektar Therapeutics | Regulatory Nektar 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 nektar.com ↗ |
| 2017-09-06 | Nektar Therapeutics | Results Nektar Therapeutics Presents Clinical Data from Phase 3 SUMMIT-07 Study of NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2017 PAINWeek® nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today presented clinical data from the SUMMIT-07 Phase 3 study of NKTR-181, a first-in-class opioid analgesic to treat chronic pain, at the 2017 PAINWeek ® Conference in Las Vegas taking place September 5-9 . |
| 2017-07-18 | Nektar Therapeutics | Results Nektar Announces Topline Data from Human Abuse Potential Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain nektar.com ↗
Nektar Therapeutics (NASDAQ: NKTR) announced positive topline results from an oral Human Abuse Potential (HAP) study of NKTR-181, a first-in-class opioid analgesic. |
| 2017-03-20 | Nektar Therapeutics | Results NKTR-181 Meets Primary and Secondary Endpoints in Phase 3 SUMMIT-07 Study in Chronic Pain nektar.com ↗
The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). |
| 2013-09-26 | Nektar Therapeutics | Results Nektar Announces Preliminary Topline Results from Phase 2 Efficacy Study for NKTR-181 in Chronic Pain Patients with Osteoarthritis of the Knee nektar.com ↗
However, patients who were randomized to placebo did not show the expected increase in pain scores observed in similar enriched enrollment, randomized withdrawal studies. |
| 2013-06-19 | Nektar Therapeutics | Results Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced positive top-line results from a human abuse liability (HAL) study for NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain. |
| 2012-06-07 | Nektar Therapeutics | Regulatory Nektar 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 nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) announced today that the U.S. Food and Drug Administration (FDA) has designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain. |
| 2012-02-27 | Nektar Therapeutics | Results Nektar Presents Positive Proof-of-Concept Clinical Data for Its New Opioid Molecule, NKTR-181, at American Academy of Pain Medicine's 28th Annual Meeting nektar.com ↗
Using pupil constriction as a measure of the onset of central opioid effect, the study showed that NKTR-181 enters the brain slowly and produces centrally-mediated opioid effects that are dose-dependent and statistically meaningful (P < 0.001) following twice daily oral doses of 200-400 mg. |
| 2011-12-13 | Nektar Therapeutics | Results Nektar Announces Positive Clinical Data from Second Phase 1 Clinical Study of NKTR-181, a Novel Opioid Analgesic Molecule to Treat Chronic Pain nektar.com ↗
In this multiple dose Phase 1 study, NKTR-181 exhibited a sustained analgesic response, supporting its development as a twice-daily oral tablet for the treatment of chronic pain conditions. |
| 2011-09-21 | Nektar Therapeutics | Results Nektar Presents Positive Data for Novel Opioid Analgesic, NKTR-181, at the 2011 American Academy of Pain Management Annual Meeting nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) today announced that positive proof-of-concept data is being presented from its first Phase 1 clinical trial of NKTR-181 at the American Academy of Pain Management (AAPM) 22nd Annual Clinical Meeting. |
| 2011-06-07 | Nektar Therapeutics | Results Data from Phase 1 Study of NKTR-181 Demonstrate Proof-of-Concept for Nektar's Novel Opioid Analgesic Candidate nektar.com ↗
Interim study results show that the molecule achieved its study objectives with an extended PK profile, slow entry into the CNS, and analgesic response. |
| 2010-11-13 | Nektar Therapeutics | Results Nektar Announces Two Preclinical Data Presentations at Society for Neuroscience 40th Annual Meeting: Neuroscience 2010 nektar.com ↗
New data from preclinical models of abuse and pain demonstrated that NKTR-181 significantly lowers abuse potential and reduces CNS-related side effects when compared with existing opioid therapies. |
| 2010-10-17 | Nektar Therapeutics | Results Nektar Presents New Preclinical Data on NKTR-181 at Anesthesiology 2010 nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today presented new preclinical data demonstrating that NKTR-181, a mu-opioid analgesic with a novel molecular structure, dramatically reduces abuse liability while providing analgesia comparable to oxycodone and morphine. |
| 2010-10-15 | Nektar Therapeutics | Results NKTR-181, A Mu-Opioid Analgesic With a Novel Molecular Structure, Demonstrates Slower Entry Rate Into the Brain and Reduced CNS Side Effects nektar.com ↗
In standard preclinical models of pain, NKTR-181 demonstrated full suppression of pain symptoms comparable to oxycodone. |
All press releases naming this drug 22 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OXYCODEGOL | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Known as | Loxicodegol | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Known as | NKTR-181 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03802227 ↗ |
| Known as | NKTR-181 phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Known as | Oxicodegol | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Known as | Oxicodegol phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Known as | OXYCODEGOL PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297632 ↗ |
| Action | Activate | “Mu opioid receptor agonist” CHEMBL4297632 ↗1“mu-opioid receptor agonist” PMID 30747908 ↗ Jun 2019 |
| Modality | Small molecule | “a new opioid molecule, NKTR-181” NCT02362672 ↗ |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL4297632 ↗ |