Overview
Naloxegol, for "PEGylated naloxol" is a peripherally-selective opioid antagonist developed by AstraZeneca. It was approved by the FDA in September 2014 and is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non‑cancer pain. The advantage of naloxegol over the opioid antagonist naloxone is that its PEGylated structure allows for high selectivity for peripheral opioid receptors and lack of entry into the central nervous system through the blood-brain barrier.
Indication
适用于治疗患有慢性非癌性疼痛的成年患者的阿片类药物引起的便秘（OIC），包括不需要频繁（如每周）增加阿片类剂量的既往癌症或其治疗相关的慢性疼痛患者。
Associated Conditions
- Opioid Induced Constipation (OIC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/16 | Phase 4 | Completed | |||
2021/08/17 | Phase 3 | Recruiting | |||
2020/06/16 | Phase 3 | Completed | CMC Ambroise Paré | ||
2019/11/22 | N/A | Completed | Kyowa Kirin Farmacéutica S.L.U. | ||
2018/10/25 | N/A | Recruiting | BioDelivery Sciences International | ||
2018/08/20 | N/A | Completed | |||
2018/05/14 | Phase 4 | Completed | |||
2017/10/20 | Phase 2 | UNKNOWN | |||
2017/08/01 | Phase 4 | Completed | |||
2017/03/22 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RedHill Biopharma Ltd | 57841-1301 | ORAL | 25 mg in 1 1 | 7/29/2020 | |
| Quality Care Products, LLC | 55700-383 | ORAL | 25 mg in 1 1 | 5/15/2020 | |
| RedHill Biopharma Ltd | 57841-1300 | ORAL | 12.5 mg in 1 1 | 7/29/2020 | |
| Valinor Pharma, LLC | 82625-8802 | ORAL | 25 mg in 1 1 | 3/28/2023 | |
| Valinor Pharma, LLC | 82625-8801 | ORAL | 12.5 mg in 1 1 | 3/28/2023 | |
| Quality Care Products, LLC | 55700-988 | ORAL | 25 mg in 1 1 | 11/28/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/7/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MOVANTIK naloxegol (as oxalate) 12.5 mg film-coated tablet blister pack | 232030 | Medicine | A | 1/7/2016 | |
| MOVANTIK naloxegol (as oxalate) 25 mg film-coated tablet blister pack | 232029 | Medicine | A | 1/7/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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