Drugs / Naloxegol
Naloxegol
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed opioid-induced constipation 2 milestones | |||||
| Filed | US (FDA) | — | opioid-induced constipation | 2013-11-19 | “partner AstraZeneca announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol” nektar.com ↗ “AstraZeneca today announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol” astrazeneca.com ↗ |
| Filed | EU (EMA) | — | opioid-induced constipation | 2013-09-27 | “In addition to the U.S., AstraZeneca has also submitted regulatory filings for MOVANTIK with health agencies in the European Union and Canada .” nektar.com ↗ “AstraZeneca today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for naloxegol” astrazeneca.com ↗ “AstraZeneca announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Naloxegol” nektar.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Moventig | — | 2014-12-07 | europa.eu ↗ |
| Approved | US (FDA) | MOVANTIK | — | 2014-09-16 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials · 1 met primary | ||||||
| Phase 1 | NCT02446171 | May → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02099591 | Nov 2014 → Apr 2021 | constipation disorder | Kyowa Kirin Pharmaceutical Development Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01594619 | May → Aug 2012 | constipation disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01533870 | Mar → May 2012 | constipation disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01520896 | Feb → Apr 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01392807 | Jul → Nov 2011 | liver disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01365000 | Jun → Aug 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01372826 | Jun → Oct 2011 | impaired renal function disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01348724 | Jun → Sep 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01325415 | Apr → Jul 2011 | cardiac rhythm disease | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01318655 | Mar → Jul 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04219046 | Mar 2021 → Sep 2022 | urinary bladder cancer | Institut Paoli-Calmettes | Unknown | No outcome recorded |
| Phase 2 | NCT02998606 | Jan 2017 → Oct 2018 | esophageal disorder, substance-related disorder | Temple University | Terminated | No outcome recorded |
| Phase 2 | NCT03036891 | Dec 2016 → Sep 2019 | gastroparesis, substance-related disorder | Temple University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00600119 | Dec 2007 → Mar 2009 | opioid-induced constipation | AstraZeneca | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03316859 | Nov 2017 → Dec 2022 | opioid-induced constipation | TriHealth Inc. | Unknown | No outcome recorded |
| Phase 38 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05008926 | Mar 2022 → Oct 2027 | brain injury | University Hospital, Brest | Suspended | No outcome recorded |
| Phase 3 | NCT04433390 | Oct 2020 → Jan 2022 | paralytic ileus | CMC Ambroise Paré | Completed | Missed primary |
| Phase 3 | NCT02705378 | May 2017 → Apr 2019 | constipation disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT01395524 | Jul 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01384292 | Jun 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01336205 | Apr 2011 → Dec 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01323790 | Mar 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT01309841 | Mar 2011 → Aug 2012 | opioid-induced constipation | AstraZeneca | Completed | Met primary |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT05770960 | Jun 2018 → May 2019 | opioid-induced constipation | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03235739 | Oct 2017 → May 2021 | neuropathy, painful | The Cleveland Clinic | Completed | Missed primary |
| Phase 4 | NCT02977286 | Jan 2017 → Oct 2019 | constipation disorder | Tufts Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02946580 | Jan 2017 → Feb 2018 | constipation disorder | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02737059 Comparator | Jul 2016 → May 2017 | opioid-induced constipation | Michael Camilleri | Completed | No outcome recorded |
| Phase 2 | NCT03087708 Comparator | Mar 2018 → Jan 2021 | non-small cell lung carcinoma | Alliance for Clinical Trials in Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02745353 Comparator | May 2016 → Jun 2017 | constipation disorder | Joseph Ma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03523520 Comparator | Dec 2020 → Mar 2023 | opioid-induced constipation | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT02839889 Comparator | Sep 2016 → Jan 2018 | cancer, constipation disorder | Hospice of Henderson County, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2022-10-26 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022 redhillbio.com ↗
This poster evaluated the efficacy of naloxegol in providing clinically meaningful HR-QOL improvement in patients with OIC. |
| 2021-10-25 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 redhillbio.com ↗
today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)1 and Movantik® (naloxegol)2 data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021. |
| 2021-09-07 | RedHill Biopharma Limited | Results RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021 redhillbio.com ↗
Additional presented data also shows that naloxegol delivers similar rapid and sustained symptom improvement for patients, irrespective of the opioid dose they are prescribed, including at doses lower than 100 mg of morphine equivalent. |
| 2021-05-24 | RedHill Biopharma Limited | Results RedHill Biopharma Presents Analyses of Movantik Onset of Action and Symptom Improvement at DDW 2021 redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced presentation at Digestive Disease Week (DDW) 2021 of two new analyses of Movantik® Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC). |
| 2014-12-09 | AstraZeneca | Regulatory MOVENTIG® approved in the European Union for opioid-induced constipation astrazeneca.com ↗
AstraZeneca today announced that MOVENTIG ® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). |
| 2014-12-09 | Nektar Therapeutics | Regulatory MOVENTIG® Approved In The European Union For Opioid-Induced Constipation nektar.com ↗
MOVENTIG ® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). |
| 2014-09-26 | AstraZeneca | Regulatory MOVENTIG® (naloxegol) receives positive CHMP opinion in the EU for the treatment of adults with opioid-induced constipation astrazeneca.com ↗
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of MOVENTIG® (naloxegol), an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA), for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). |
| 2014-09-26 | Nektar Therapeutics | Regulatory Nektar Therapeutics Announces MOVENTIG® (naloxegol) Receives Positive CHMP Opinion In EU For Treatment Of Adults With Opioid-Induced Constipation nektar.com ↗
The CHMP's positive opinion on MOVENTIG will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union . |
| 2014-09-16 | AstraZeneca | Regulatory FDA approves MOVANTIK™ (naloxegol) tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain astrazeneca.com ↗ |
| 2014-09-16 | Nektar Therapeutics | Regulatory FDA approves MOVANTIK™ (naloxegol) Tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain nektar.com ↗
The FDA approval of MOVANTIK was based on data from the KODIAC clinical programme, which is comprised of four studies: KODIAC-4, -5, -7 and -8. |
| 2014-06-19 | Nektar Therapeutics | Results Data Published in the New England Journal of Medicine Demonstrate that Naloxegol Improved Opioid-Induced Constipation in Chronic Pain Patients nektar.com ↗
The 12.5 mg dose in KODIAC-5 did not show statistical significance for the primary endpoint. |
| 2014-06-12 | AstraZeneca | Regulatory US FDA Advisory Committee recommends no cardiovascular outcomes trial for peripherally-acting mu-opioid receptor antagonist (PAMORA) class including MOVANTIK astrazeneca.com ↗
We are pleased that the Committee did not find it necessary to require a cardiovascular outcomes trial for the PAMORA class. |
| 2014-06-12 | Nektar Therapeutics | Regulatory US FDA ADVISORY COMMITTEE RECOMMENDS NO CARDIOVASCULAR OUTCOMES TRIAL FOR PERIPHERALLY-ACTING MU-OPIOID RECEPTOR ANTAGONIST (PAMORA) CLASS INCLUDING MOVANTIK nektar.com ↗
Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. |
| 2013-11-19 | AstraZeneca | Regulatory New Drug Application for naloxegol accepted by United States Food and Drug Administration astrazeneca.com ↗
AstraZeneca today announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA), which has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain medicines. |
| 2013-11-19 | Nektar Therapeutics | Regulatory New Drug Application For Naloxegol Accepted By United States Food And Drug Administration nektar.com ↗ |
| 2013-09-30 | Nektar Therapeutics | Regulatory Nektar Reports that Partner AstraZeneca Announced European Medicines Agency Acceptance of Marketing Authorisation Application for Naloxegol nektar.com ↗
AstraZeneca announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Naloxegol |
| 2013-09-27 | AstraZeneca | Regulatory Marketing Authorisation Application for naloxegol accepted by European Medicines Agency astrazeneca.com ↗
AstraZeneca today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation (OIC) for adult patients 18 years and older, including patients with inadequate response to laxatives. |
| 2013-02-26 | AstraZeneca | Results AstraZeneca announces results from long-term safety trial of naloxegol in patients with opioid-induced constipation astrazeneca.com ↗
AstraZeneca today announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC). |
| 2013-02-26 | Nektar Therapeutics | Results AstraZeneca Announces Results From Long-Term Safety Trial Of Naloxegol In Patients With Opioid-Induced Constipation nektar.com ↗
AstraZeneca today announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC). |
| 2012-11-12 | AstraZeneca | Results AstraZeneca announces top-line phase III results from naloxegol pivotal trials in patients with opioid-induced constipation astrazeneca.com ↗
AstraZeneca today announced positive top-line results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC). |
| 2012-11-12 | Nektar Therapeutics | Results AstraZeneca Announces Top-line Phase III Results from Naloxegol Pivotal Trials In Patients With Opioid-Induced Constipation nektar.com ↗
AstraZeneca today announced positive top-line results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC). |
| 2009-10-27 | Nektar Therapeutics | Results Phase 2 Data From Oral NKTR-118 Presented at American College of Gastroenterology in San Diego nektar.com ↗
Data from a phase II study demonstrated that oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia. |
| 2009-10-10 | Nektar Therapeutics | Results Topline Results from Phase 2 Clinical Trial of Oral NKTR-118 Presented at 20th American Academy of Pain Management Annual Clinical Meeting (AAPM) in Phoenix nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) presented topline data today from its Phase 2 clinical trial of oral NKTR-118 at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting in Phoenix, Arizona. |
| 2009-09-13 | Nektar Therapeutics | Results Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug-Drug Interaction Profile for NKTR-118 nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) presented clinical study data today demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions. |
| 2009-03-02 | Nektar Therapeutics | Results Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC) nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) announced positive topline results today from a Phase 2 double-blind, randomized, placebo-controlled study of NKTR-118 in patients with opioid-induced constipation (OIC). |
| 2008-05-07 | Nektar Therapeutics | Results NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life in Phase 1 Clinical Data Presented at American Pain Society Meeting nektar.com ↗
In this multiple-dose Phase 1 study, oral NKTR-118 was shown to have substantial oral bioavailability with rapid absorption and an extended half-life that is up to ten times the known half-life of unPEGylated naloxone. |
| 2007-09-26 | Nektar Therapeutics | Results Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting nektar.com ↗
Data from a single-dose, proof-of-principle Phase 1 trial on NKTR-118 demonstrate that the drug antagonized the morphine-induced delay in gastrointestinal (GI) transit time without reversing the central opioid effect as measured by pupillometry. |
| 2007-09-10 | Nektar Therapeutics | Results Nektar Presents Positive Results from Phase 1 Clinical Trial of NKTR-118 (oral PEG-naloxol) at American College of Clinical Pharmacology Meeting nektar.com ↗
The NKTR-118 Phase 1 results demonstrate that single oral doses of NKTR-118 reverse the effects of morphine on gastrointestinal transit time at doses that do not reverse a central opiate effect as measured by pupillometry. |
| 2007-07-26 | Nektar Therapeutics | Results First Peer-Reviewed Preclinical and Early Phase 1 Results for NKTR-118 (oral PEG-naloxol) to be Presented at Upcoming Pharmacology and Pain Management Meetings nektar.com ↗
This first Phase 1 study indicates that NKTR-118 may have the potential to mitigate the constipation side effect of opioid drugs without compromising their analgesic effects. |
All press releases naming this drug 58 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | naloxegol | “AIM: To evaluate the long-term safety and tolerability of naloxegol, an oral, peripherally acting μ-opioid receptor antagonist (PAMORA), in patients with noncancer pain and OIC.” PMID 25112584 ↗ Aug 201420“MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation.” NCT02998606 ↗ “The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol.” PMID 24946021 ↗ Jul 2014 |
| Known as | Movantik | “Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until...” NCT02946580 ↗1“Movantik (Naloxegol) is an opioid agonist specifically designed to work outside of the central nervous system.” NCT03036891 ↗ |
| Known as | Naloxégol oxalate | “Drug: Naloxégol oxalate” NCT04219046 ↗ |
| Known as | NKTR118 | “Assessment of Relative Bioavailability of NKTR-118 in Three Formulations” NCT01365000 ↗ |
| Known as | PEG-Naloxol | “A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)” NCT00600119 ↗ |
| Action | Inhibit | “an oral, peripherally acting, μ-opioid receptor antagonist” PMID 24896818 ↗ Jun 2014 |
| Route | Oral | “5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)” NCT00600119 ↗ |