Overview
Naldemedine is an opioid receptor antagonist . It is a modified form of Naltrexone to which a side chain has been added to increase molecular weight and polar surface area resulting in restricted transport across the blood brain barrier. Naldemedine was approved in 2017 in both the US and Japan for the treatment of Opioid-induced Constipation.
Background
Naldemedine is an opioid receptor antagonist . It is a modified form of Naltrexone to which a side chain has been added to increase molecular weight and polar surface area resulting in restricted transport across the blood brain barrier. Naldemedine was approved in 2017 in both the US and Japan for the treatment of Opioid-induced Constipation.
Indication
For the treatment of opioid-induced constipation .
Associated Conditions
- Opioid Induced Constipation (OIC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/26 | Phase 4 | Recruiting | |||
2024/03/27 | Phase 2 | Recruiting | Asbjørn Mohr Drewes | ||
2022/10/20 | Phase 1 | Recruiting | |||
2021/07/19 | Phase 2 | Active, not recruiting | Asbjørn Mohr Drewes | ||
2020/04/21 | Phase 2 | Terminated | |||
2018/10/25 | N/A | Recruiting | BioDelivery Sciences International | ||
2013/11/25 | Phase 3 | Completed | |||
2013/10/18 | Phase 3 | Completed | |||
2013/10/18 | Phase 3 | Completed | |||
2011/09/29 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BioDelivery Sciences International Inc | 59385-041 | ORAL | 0.2 mg in 1 1 | 7/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||