Dinalbuphine sebacate
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04256434 | Jan → May 2020 | — | Lumosa Therapeutics Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05187520 | Sep 2022 → Jun 2023 | chronic pain syndrome | E-DA Hospital | Unknown | No outcome recorded |
| Phase 47 trials · 2 met primary | ||||||
| Phase 4 | NCT07140510 | Oct 2025 → Jun 2026 overdue | osteoarthritis, knee | Thammasat University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05266027 | Apr → Nov 2022 | arthropathy | Kaohsiung Medical University Chung-Ho Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05115955 | Nov 2021 → May 2024 | — | Tri-Service General Hospital (TSGH) | Completed | No outcome recorded |
| Phase 4 | NCT04962152 | Jul 2021 → May 2024 | — | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | Met primary |
| Phase 4 | NCT03854851 | Mar → Jul 2019 | — | China Medical University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03713216 | Jul 2018 → Oct 2019 | — | Cathay General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03296488 | Aug 2017 → Dec 2018 | neuropathy, painful | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT05842733 Comparator | Jul 2023 → Dec 2024 | neuropathy, painful | Sinew Pharma Inc. | Unknown | No outcome recorded |
| Phase 2/3 | NCT04808544 Comparator | Aug 2021 → Jan 2022 | cholecystitis, chronic pain syndrome, neuropathy, painful | E-DA Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT04651361 Comparator | Jun 2021 → Mar 2022 | chronic pain syndrome, neuropathy, painful, obesity disorder | E-DA Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05825495 Comparator | May 2023 → Apr 2024 | neuropathy, painful, obstructive sleep apnea syndrome | Li-Jen Hsin | Unknown | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dinalbuphine sebacate | “Naldebain (extended-release dinalbuphine sebacate, DS) is an oil-based formulation for intramuscular injection that has been designed for extended release and can be used for...” PMID 32982387 ↗ Sep 20209“Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial.” PMID 32990938 ↗ Sep 2020 “Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine.” NCT05187520 ↗ “Dinalbuphine sebacate (DS), a long-acting prodrug of nalbuphine, was chosen due to its potential to enhance MMA strategies.” PMID 40382572 ↗ May 2025 “150 mg Dinalbuphine Sebacate, 75 mg/ml, 2 ml/vial” NCT05115955 ↗ |
| Known as | Nalbuphine Sebacate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05266027 ↗ |
| Known as | Naldebain | “Naldebain (extended-release dinalbuphine sebacate, DS) is an oil-based formulation for intramuscular injection that has been designed for extended release and can be used for...” PMID 32982387 ↗ Sep 20205“Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine.” NCT05187520 ↗ “Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.” NCT05266027 ↗ “Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine.” NCT04962152 ↗ |
| Known as | SDE | “single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL)” PMID 27518486 ↗ May 2017 |
| Known as | Sebacate de dinalbuphine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1823241 ↗ |
| Known as | Sebacato de dinalbufina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1823241 ↗ |
| Known as | sebacoyl dinalbuphine ester | “single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL)” PMID 27518486 ↗ May 2017 |
| Known as | Sebacoyldinalbuphine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1823241 ↗ |
| Modality | Other / unclassified | “is a nalbuphine synthetic prodrug” NCT03854851 ↗ |
| Modality | Small molecule | — CHEMBL1823241 ↗ |
| Route | Intramuscular | “by intramuscular injection” NCT03854851 ↗ |