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Movantik (NALOXEGOL)
Movantik (generic name: NALOXEGOL) is a Opioid Antagonist Small molecule drug developed by Averitas. It is currently FDA-approved (first approved 2014) for Therapeutic opioid induced constipation.
Movantik works by blocking the mu-type opioid receptor, which is responsible for the constipating effects of opioids.
Movantik is a small molecule used to treat Opioid-Induced Constipation (OIC). It is administered as NKTR-118 and has been studied in clinical trials for its safety and efficacy in patients with non-cancer-related pain and OIC.
At a glance
| Generic name | NALOXEGOL |
|---|---|
| Sponsor | Averitas |
| Drug class | Opioid Antagonist |
| Target | Mu-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
Mechanism of action
Naloxegol is an antagonist of opioid binding at the mu-opioid receptor. When administered at the recommended dose levels, naloxegol functions as peripherally-acting mu-opioid receptor antagonist in tissues, such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.Naloxegol is PEGylated derivative of naloxone and is substrate for the P-glycoprotein transporter (P-gp). Also, the presence of the PEG moiety in naloxegol reduces its passive permeability as compared with naloxone. Due to the reduced permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is expected to be negligible at the recommended dose levels limiting the potential for interference with centrally mediated opioid analgesia.
Approved indications
- Therapeutic opioid induced constipation
Common side effects
- Abdominal Pain
- Diarrhea
- Nausea
- Flatulence
- Vomiting
- Headache
- Hyperhidrosis
- Opioid Withdrawal
- Gastrointestinal Pain
- Gastrointestinal Perforation
- Angioedema
- Rash
Key clinical trials
- The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients (PHASE3)
- Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer (PHASE2)
- Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
- Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation (PHASE4)
- Naloxegol Health Outcome Post Authorisation Safety Study
- Naloxegol Drug Utilization Post Authorisation Safety Study
- Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients (PHASE1)
- Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Movantik CI brief — competitive landscape report
- Movantik updates RSS · CI watch RSS
- Averitas portfolio CI
Frequently asked questions about Movantik
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Related
- Drug class: All Opioid Antagonist drugs
- Target: All drugs targeting Mu-type opioid receptor
- Manufacturer: Averitas — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Therapeutic opioid induced constipation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing