Drugs / Cebranopadol
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06453265 | Jun → Nov 2024 | substance abuse | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05491785 | Jul 2022 → Mar 2023 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05256108 | Mar → Jul 2022 | substance abuse | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03958123 | Jul → Nov 2013 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03882762 | Jun 2013 → Sep 2014 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03757559 | Apr 2013 → Mar 2014 | substance abuse | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT01939366 | Sep 2013 → Jan 2015 | chronic pain syndrome, diabetes mellitus, diabetic neuropathy | Tris Pharma, Inc. | Completed | Met primary |
| Phase 2 | NCT01709214 | Dec 2012 → Apr 2014 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01725087 | Nov 2012 → Jul 2014 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01357837 | May → Dec 2011 | osteoarthritis, knee | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00878293 | Apr 2009 → May 2010 | diabetic polyneuropathy | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00872885 | Mar → Aug 2009 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT07845071 | Sep 2026 → Jan 2027 expected | — | Adneuris Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06545097 | Sep → Dec 2024 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT06423703 | Jul 2024 → Jan 2025 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02031432 | Dec 2013 → Apr 2016 | chronic pain syndrome, neoplasm | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01964378 | Oct 2013 → Oct 2015 | chronic pain syndrome, neoplasm | Tris Pharma, Inc. | Terminated | Met primary Stop: Enrollment |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01347671 Comparator | May 2011 → Jan 2012 | diabetic polyneuropathy | Tris Pharma, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2016-02-29 | Assertio Holdings, Inc | Results Cebranopadol Top-Line Data From Phase IIb Trial in Chronic Lower Back Pain Demonstrate Clinically and Statistically Significant Improvements in Pain Across All Arms assertiotx.com ↗
Results from the cLBP trial showed clinically and statistically significant improvements in pain at all three doses tested. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2016-02-29 | Assertio Holdings, Inc | Cebranopadol Top-Line Data From Phase IIb Trial in Chronic Lower Back Pain Demonstrate Clinically and Statistically Significant Improvements in Pain Across All Arms assertiotx.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cebranopadol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05256108 ↗ |
| Known as | GRT6005 | “The objective of this study was to evaluate the pharmacokinetics (PK), safety and tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal...” NCT03882762 ↗8“The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants.” NCT03958123 ↗ “The primary objective of this study was to evaluate the abuse potential of single doses of cebranopadol (GRT6005) relative to hydromorphone” NCT03757559 ↗ “Cebranopadol (GRT6005) Low-Dose Range” NCT01709214 ↗ |
| Action | Activate | “opioid peptide receptor agonism” PMID 30365202 ↗ Jan 20191“Nociceptin receptor agonist” CHEMBL2364605 ↗ |
| Modality | Small molecule | — CHEMBL2364605 ↗ |
| Route | Oral | “liquid formulation for oral application” NCT00878293 ↗ |
| Target | OPRL1 | “Nociceptin receptor agonist” CHEMBL2364605 ↗ |