Drugs / Nalbuphine
Nalbuphine
also known as
NAL ER · Nalbuphine hydrochloride · Nalbuphine HCl · nalufin · EN-2234A · Intapan · Nalbufina · Nalbufine hydrochloride · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NUBAIN | — | 1986-10-23 | fda.gov ↗ |
| Approved | US (FDA) | NUBAIN | — | 1979-05-15 | fda.gov ↗ |
Trials 68 · started per year
today
US approved 1979
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05298761 | Dec 2023 → Mar 2024 | — | Sheikh Zayed Medical College | Unknown | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT07487740 | Feb → Apr 2026 overdue | — | Trevi Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT07036029 | Aug 2025 → Jun 2026 overdue | idiopathic pulmonary fibrosis | Trevi Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT07015398 | Jun → Sep 2025 | — | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06902103 | Dec 2023 | — | Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04020016 | Jun 2019 → Feb 2020 | — | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04018664 | May → Dec 2018 | opioid abuse | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02446301 | Jan → Apr 2015 | neurological pain disorder | Lumosa Therapeutics Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02373215 | Apr → Nov 2013 | — | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00923000 | Dec 2008 → Dec 2009 | — | Tri-Service General Hospital (TSGH) | Unknown | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07671924 | Jun 2026 → Sep 2027 expected | — | Trevi Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT05964335 | Feb 2024 → Apr 2025 | idiopathic pulmonary fibrosis | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT05962151 | Nov 2023 → Jan 2025 | respiratory system disorder | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT04030026 | Oct 2019 → May 2022 | idiopathic pulmonary fibrosis | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03470077 | Jul 2019 → Sep 2020 | — | Assiut University | Completed | No outcome recorded |
| Phase 2 | NCT03034382 | Jan 2016 → May 2017 | rotator cuff syndrome | Assiut University | Unknown | No outcome recorded |
| Phase 2/38 trials | ||||||
| Phase 2/3 | NCT06996561 | Sep 2025 → Jan 2027 expected | appendicitis, gallbladder disorder, urinary bladder disorder | Dr. Asma Abdus Salam | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06785571 | Aug 2023 → Oct 2025 overdue | respiratory failure | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03497975 | Aug 2018 → May 2022 | prurigo nodularis | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT02174432 | Aug 2015 → Sep 2017 | prurigo, prurigo nodularis | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT02174419 | Mar 2015 → Aug 2016 | prurigo, prurigo nodularis | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT02143973 | Sep 2014 → Jan 2016 | — | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT02143648 | Jun 2014 → Jul 2015 | prurigo | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 2/3 | NCT02193620 | Apr 2013 → Sep 2014 | — | PhytoHealth Corporation | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07671911 | Jun 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Trevi Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT06949852 | Aug 2024 → Jul 2025 | — | Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 3 | NCT06306040 | Apr → Nov 2024 | delirium | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT05576675 | May 2018 → Mar 2022 | — | Xijing Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03825887 | Feb 2018 → Dec 2020 | acute myeloid leukemia | Children's Cancer Hospital Egypt 57357 | Completed | No outcome recorded |
| Phase 3 | NCT00323154 | Mar → Dec 2004 | — | University of British Columbia | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT07271849 | Oct 2025 → Oct 2026 expected | — | Qianfoshan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06722963 | Jan 2025 → Jan 2026 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06720506 | Jan 2025 → Jan 2026 overdue | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06736496 | Jan 2025 → Jan 2026 overdue | gallbladder disorder | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06490614 | Jul → Oct 2024 overdue | — | Kasr El Aini Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07008443 | Jan 2024 → Apr 2025 | — | Alzahraa Ahmed Abbas | Completed | No outcome recorded |
| Phase 4 | NCT06037330 | Sep 2023 → Apr 2026 overdue | acute respiratory distress syndrome | Hairong Chen | Recruiting | No outcome recorded |
| Phase 4 | NCT05769530 | May 2023 → May 2025 | — | Lili Jia | Completed | No outcome recorded |
| Phase 4 | NCT05689242 | Mar 2023 → Mar 2024 | — | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT05273671 | Mar → Jun 2022 | — | Alexandria University | Unknown | No outcome recorded |
| Phase 4 | NCT05073744 | Sep 2021 → Aug 2023 | drug pseudoallergy | Zhongda Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04372342 | May 2019 → Jan 2021 | — | Chun Pan | Unknown | No outcome recorded |
| Phase 4 | NCT03786887 | Oct 2018 → Oct 2019 | — | Hua-Qing Shu | Unknown | No outcome recorded |
| Phase 4 | NCT03826316 | Jan → Nov 2018 | neuropathy, painful | Yung Shin Pharm. Ind. Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03288428 | May 2017 → Dec 2018 | — | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00155233 | Jan 2005 → ? | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase not applicable22 trials | ||||||
| — | NCT07422558 | Mar → Aug 2026 overdue | — | Hayatabad Medical Complex | Not yet recruiting | No outcome recorded |
| — | NCT07294352 | Jan → Jul 2026 overdue | — | CMH Lahore Medical College and Institute of Dentistry | Active not recruiting | No outcome recorded |
| — | NCT07340008 | Sep 2025 → Jan 2028 expected | cleft lip/palate, congenital alveolar dysplasia | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| — | NCT07009808 | Jun → Oct 2025 overdue | anxiety, depressive disorder, ectopic pregnancy | Chengdu Jinjiang Maternity and Child Health Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07348159 | Mar → Dec 2024 | — | Dr. Waseem Ullah | Completed | No outcome recorded |
| — | NCT06594224 | Mar → Aug 2024 | — | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT06153602 | Dec 2023 → Nov 2024 | — | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT06837129 | Nov 2023 → Feb 2025 | — | Thammasat University | Completed | No outcome recorded |
| — | NCT07543913 | Apr 2023 → Jan 2024 | — | Sargodha Medical College | Completed | No outcome recorded |
| — | NCT04932083 | Jun 2021 → Jan 2022 | — | Benha University | Completed | No outcome recorded |
| — | NCT04689217 | Jan → Apr 2021 | — | Cairo University | Completed | No outcome recorded |
| — | NCT04483427 | Sep 2020 → Jul 2022 | obstructive sleep apnea syndrome | Bahaa Mohammed Refaie | Unknown | No outcome recorded |
| — | NCT04135534 | Nov 2019 → Nov 2020 | — | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | No outcome recorded |
| — | NCT03562611 | Jun → Sep 2018 | — | Sun Yat-sen University | Completed | No outcome recorded |
| — | NCT03422887 | Jan → Aug 2018 | — | Sun Yat-sen University | Completed | No outcome recorded |
| — | NCT03436836 | Jan → Feb 2018 | — | Cairo University | Completed | No outcome recorded |
| — | NCT02984865 | Dec 2016 → Apr 2018 | — | The First Affiliated Hospital of Anhui Medical University | Unknown | No outcome recorded |
| — | NCT02604797 | Jan 2016 → Jan 2017 | — | Fudan University | Unknown | No outcome recorded |
| — | NCT00947284 | Jan 2010 → Jun 2012 | — | University of California, San Francisco | Terminated | No outcome recorded |
| — | NCT00924079 | Sep 2008 → Nov 2009 | — | Tri-Service General Hospital (TSGH) | Unknown | No outcome recorded |
| — | NCT00716807 | Jan 2008 → Jun 2010 | burning mouth syndrome, temporomandibular joint dysfunction syndrome | University of California, San Francisco | Terminated | No outcome recorded |
| — | NCT00200590 | Dec 2003 → Jul 2006 | — | Nantes University Hospital | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 49 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05880459 Comparator | Aug 2023 → Nov 2024 | — | Assiut University | Unknown | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07279727 Comparator | Jan → Dec 2026 expected | — | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05276206 Comparator | Mar 2022 | — | Egymedicalpedia | Completed | No outcome recorded |
| Phase 1 | NCT05245721 Comparator | Mar 2022 → Jan 2023 | — | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT04256434 Comparator | Jan → May 2020 | — | Lumosa Therapeutics Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03918187 Comparator | Apr → Aug 2019 | — | Zagazig University | Completed | No outcome recorded |
| Phase 1 | NCT03059511 Comparator | Mar 2017 → Jan 2018 | — | University Children's Hospital, Zurich | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04058899 Comparator | Mar → Sep 2019 | delirium | Ain Shams University | Unknown | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06577155 Comparator | Aug 2024 → Jan 2025 | — | Asklepieion Voulas General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT06633068 Comparator | Jul 2024 → Apr 2025 overdue | — | Cairo University | Recruiting | No outcome recorded |
| Phase 2 | NCT05327088 Comparator | Sep 2021 → Feb 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT04589429 Comparator | Oct 2020 → Mar 2021 | — | Minia University | Unknown | No outcome recorded |
| Phase 2 | NCT03933280 Comparator | Jul 2019 → Dec 2020 | — | Menoufia University | Completed | No outcome recorded |
| Phase 2 | NCT02716129 Comparator | Jul 2016 → Oct 2017 | — | Abdelrady S Ibrahim, MD | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06830564 Comparator | May → Nov 2024 | delirium | Ain Shams University | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01380197 Comparator | May 2010 → Jan 2014 | sickle cell disease | Children's Healthcare of Atlanta | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT07613801 Comparator | May → Nov 2026 expected | — | Liaquat National Hospital & Medical College | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07435337 Comparator | Feb → May 2026 overdue | — | Rawalpindi Institute of Cardiology | Recruiting | No outcome recorded |
| Phase 4 | NCT07269106 Comparator | Jan 2026 → Dec 2027 expected | — | Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT05565235 Comparator | Dec 2022 → Sep 2023 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT05176119 Comparator | Mar → Jun 2021 | childhood acute lymphoblastic leukemia | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03824665 Comparator | Feb → May 2019 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT03393572 Comparator | Jan → Jun 2018 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02445599 Background | Apr 2014 → Apr 2016 | lung disorder | University of Debrecen | Completed | No outcome recorded |
| Phase 4 | NCT00707824 Comparator | Jun 2000 → Dec 2005 | — | Mahidol University | Completed | No outcome recorded |
| Phase not applicable24 trials | ||||||
| — | NCT07197684 Background | Mar → Dec 2026 expected | breast cancer, chronic pain syndrome | Aga Khan University | Not yet recruiting | No outcome recorded |
| — | NCT07384000 Comparator | Jan → Mar 2026 overdue | — | Minia University | Not yet recruiting | No outcome recorded |
| — | NCT07268911 Comparator | Nov 2025 → May 2026 overdue | — | South Valley University | Recruiting | No outcome recorded |
| — | NCT07479069 Background | Oct 2025 → Mar 2026 overdue | — | Fatima Memorial Hospital | Active not recruiting | No outcome recorded |
| — | NCT07067996 Comparator | Jun → Dec 2025 overdue | nephrolithiasis | Sohag University | Recruiting | No outcome recorded |
| — | NCT07401641 Comparator | Jun 2025 → Jun 2026 overdue | oral cavity cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06818396 Comparator | Feb 2025 → Oct 2026 expected | — | Ain Shams University | Recruiting | No outcome recorded |
| — | NCT07110051 Comparator | Jan → Sep 2025 overdue | childhood malignant neoplasm | National Cancer Institute, Egypt | Recruiting | No outcome recorded |
| — | NCT06476600 Comparator | Jul → Oct 2024 | gallbladder disorder | Atif Shafqat | Completed | No outcome recorded |
| — | NCT06155968 Comparator | Dec 2023 → May 2024 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT05975294 Comparator | Aug 2023 → Aug 2024 | — | Sohag University | Unknown | No outcome recorded |
| — | NCT05704673 Comparator | Jun → Dec 2023 | — | Assiut University | Unknown | No outcome recorded |
| — | NCT05746351 Comparator | Mar 2023 → Mar 2025 | — | Assiut University | Unknown | No outcome recorded |
| — | NCT03150732 Comparator | Aug 2022 → Feb 2024 | — | Assiut University | Completed | No outcome recorded |
| — | NCT05347173 Comparator | Jun 2022 → Jan 2024 | — | Mansoura University | Completed | No outcome recorded |
| — | NCT05041270 Comparator | Oct 2021 → Apr 2022 | — | Zagazig University | Completed | No outcome recorded |
| — | NCT03786562 Comparator | Mar 2019 → Mar 2020 | abdominal obesity-metabolic syndrome | Assiut University | Unknown | No outcome recorded |
| — | NCT03798522 Comparator | Feb → Aug 2019 | morbid obesity | Cairo University | Completed | No outcome recorded |
| — | NCT03476772 Comparator | Mar 2018 → Mar 2020 | — | Assiut University | Completed | No outcome recorded |
| — | NCT03535792 Comparator | Nov 2017 → Aug 2018 | — | University of Alexandria | Completed | No outcome recorded |
| — | NCT03276325 Comparator | Sep 2017 → Jan 2018 | — | Mansoura University | Completed | No outcome recorded |
| — | NCT02678585 Comparator | Dec 2015 → Mar 2016 | — | Assiut University | Completed | No outcome recorded |
| — | NCT02618876 Comparator | Nov 2015 → Dec 2019 | — | Assiut University | Completed | No outcome recorded |
| — | NCT02820051 Background | Feb → Jul 2014 | — | Hospital Universitario Dr. Jose E. Gonzalez | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 119 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nalbuphine | “The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer...” NCT01380197 ↗112“Pharmacokinetic Study of Single and Multiple Intravenous Administration of Nalbuphine Hydrochloride Injection in Healthy Chinese Volunteers” NCT06902103 ↗ “Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects.” NCT04689217 ↗ “A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants” NCT07487740 ↗ “The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)” NCT07671924 ↗ “Oral Nalbuphine in Idiopathic Pulmonary Fibrosis-Associated Cough: The CORAL Randomized Clinical Trial.” PMID 41569557 ↗ Mar 2026 “The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min” NCT06155968 ↗ “Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis.” PMID 38320144 ↗ May 2023 “Intravenous Nalbuphine in Decreasing Postoperative Pain in Cesarean Section” NCT05276206 ↗ “I/v nalbuphine 0.1mg per kg given to participants in stat dose” NCT05298761 ↗ “they receive rescue analgesia in the form of nalbuphine 4mg” NCT07479069 ↗ “Nalbuphine is a FDA approved noncontrolled drug of opioid.” NCT04135534 ↗ “the other received nalbuphine (0.2 mg/kg IV).” PMID 41310459 ↗ Nov 2025 “IV nalbuphine (6 mg bolus PRN when NRS\>4 )” NCT07268911 ↗ “Nalbuphine” NCT07671911 ↗ |
| Known as | EN-2234A | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | Intapan | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | NAL ER | “OBJECTIVE: To evaluate the efficacy and safety of two oral doses of the kappa opioid agonist and mu opioid antagonist nalbuphine extended release (NAL-ER) tablets in a phase 2,...” PMID 34780095 ↗ Dec 20216“A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants” NCT07487740 ↗ “The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)” NCT07671924 ↗ “administered nalbuphine extended-release tablets (NAL ER) as a potential cough therapy for such patients.” PMID 38320144 ↗ May 2023 |
| Known as | Nalbufina | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | Nalbufine hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | nalbuphine extended release | “OBJECTIVE: To evaluate the efficacy and safety of two oral doses of the kappa opioid agonist and mu opioid antagonist nalbuphine extended release (NAL-ER) tablets in a phase 2,...” PMID 34780095 ↗ Dec 2021 |
| Known as | Nalbuphine HCl | “Nalbuphine HCl 20mg, IM injection” NCT02446301 ↗1“Drug: Nalbuphine HCl” NCT04256434 ↗ |
| Known as | Nalbuphine hydrochloride | “Nalbuphine hydrochloride has strong analgesic effect, quick effect and long time by stimulating receptor, and has partial antagonistic effect on the receptor, so the incidence...” NCT04372342 ↗2“Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1ml nalbuphine hydrochloride (1.6 mg); (nalufin 20 mg in 1 ml ampoule, Amoun...” NCT03535792 ↗ “Nalbuphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under...” NCT05073744 ↗ |
| Known as | nalufin | “39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg...” NCT02716129 ↗1“Patients will receive intrathecal injection of 2 ml of 0.5% hyperbaric bupivacaine plus 1ml nalbuphine hydrochloride (1.6 mg); (nalufin 20 mg in 1 ml ampoule, Amoun...” NCT03535792 ↗ |
| Known as | NSC-757829 | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | Nubain | ChEMBL registry synonym — accepted as the source's own label CHEMBL895 ↗ |
| Known as | Nubian | “The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.” NCT00923000 ↗ |
| Action | Activate | “κ receptor agonist/μ receptor partial antagonistic type analgesia drug” NCT02604797 ↗ |
| Modality | Small molecule | “Nalbuphine is a small molecular weight, water-soluble molecule” NCT02373215 ↗ |
| Route | Intravenous | “50 - 100 mcg/kg intravenously” NCT00323154 ↗ |