Drugs / Naldemedine
Naldemedine
also known as
Naldemedina · Naldemedine tosilate · Naldemedine Tosylate · Rizmoic · S-297995 · Symproic
Other / unclassified targets OPRM1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rizmoic | — | 2019-02-18 | europa.eu ↗ |
| Approved | US (FDA) | SYMPROIC | — | 2017-03-23 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05588323 | Jan 2023 → Jun 2026 overdue | opioid-induced constipation | Shionogi | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04355169 | Nov 2020 → Jan 2021 | intestinal dysmotility syndrome | Shionogi | Terminated | No outcome recorded |
| Phase 2 | NCT01443403 | Aug 2011 → Aug 2012 | opioid-induced constipation | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT01122030 | May 2010 → Feb 2011 | opioid-induced constipation | Shionogi | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01993940 | Nov 2013 → Jun 2015 | opioid-induced constipation | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT01965652 | Sep 2013 → Jan 2016 | opioid-induced constipation | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT01965158 | Aug 2013 → Jan 2015 | opioid-induced constipation | Shionogi | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06334198 Comparator | Mar 2024 → Mar 2025 | opioid-induced constipation | Asbjørn Mohr Drewes | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04966559 Comparator | Jan 2022 → Mar 2024 | acute pancreatitis | Asbjørn Mohr Drewes | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07038551 Comparator | Jun 2025 → Feb 2026 | — | International University of Health and Welfare | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | naldemedine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04966559 ↗ |
| Known as | Naldemedina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105755 ↗ |
| Known as | Naldemedine tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105755 ↗ |
| Known as | Naldemedine Tosylate | “Naldemedine Tosylate (0,2 mg)” NCT04966559 ↗ |
| Known as | Rizmoic | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105755 ↗ |
| Known as | S-297995 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105755 ↗ |
| Known as | Symproic | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105755 ↗ |
| Action | Inhibit | “Naldemedine, an oral, peripherally acting μ-opioid receptor antagonist approved for the treatment of opioid-induced constipation (OIC), is renally excreted.” PMID 32280263 ↗ Mar 20201“Mu opioid receptor antagonist” CHEMBL2105755 ↗ |
| Modality | Other / unclassified | “peripheral acting µ-opioid receptor antagonist (PAMORA)” NCT04966559 ↗ |
| Route | Oral | “administered orally” NCT01122030 ↗ |
| Target | OPRM1 | “Mu opioid receptor antagonist” CHEMBL2105755 ↗ |