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 67 · 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 17 trials · 1 met primary | ||||||
| Phase 1 | NCT07487740 | Feb → Apr 2026 overdue | — | Trevi Therapeutics | Recruiting | 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 | Met primary |
| 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 25 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT04030026 | Oct 2019 → May 2022 | idiopathic pulmonary fibrosis | Trevi Therapeutics | Completed | Met primary |
| 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 · 2 met primary | ||||||
| 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 | Met primary |
| 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 | Met primary |
| Phase 2/3 | NCT02193620 | Apr 2013 → Sep 2014 | — | PhytoHealth Corporation | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07868419 | Sep 2026 → Aug 2027 expected | idiopathic pulmonary fibrosis | Trevi Therapeutics | Recruiting | No outcome recorded |
| 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 417 trials | ||||||
| Phase 4 | NCT07837492 | Oct 2026 → Oct 2027 expected | — | Assiut University | Not yet recruiting | No outcome recorded |
| 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 | NCT06736496 | Jan 2025 → Jan 2026 overdue | gallbladder disorder | 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 | 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 | — | CMH Lahore Medical College and Institute of Dentistry | Completed | 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 |
| — | NCT06594224 | Mar → Aug 2024 | — | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT07348159 | Mar → Dec 2024 | — | Dr. Waseem Ullah | 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 Stop: Enrollment |
| — | NCT00200590 | Dec 2003 → Jul 2006 | — | Nantes University Hospital | Terminated | No outcome recorded |
| Comparator or background therapy51 trials | ||||||
| Phase 0 | NCT05880459 Comparator | Aug 2023 → Nov 2024 | — | Assiut University | Unknown | No outcome recorded |
| 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 1/2 | NCT04058899 Comparator | Mar → Sep 2019 | delirium | Ain Shams University | Unknown | No outcome recorded |
| 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 2/3 | NCT06830564 Comparator | May → Nov 2024 | delirium | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT06100315 Comparator | Jul 2023 → Oct 2025 | peripheral nerve lesion | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT01380197 Comparator | May 2010 → Jan 2014 | sickle cell disease | Children's Healthcare of Atlanta | Completed | No outcome recorded |
| 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 | NCT07838948 Background | Apr → Oct 2025 | — | Wuhan Fourth Hospital | Completed | 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 |
| — | 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 | Missed primary |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-01-22 | Trevi Therapeutics | Results Trevi Therapeutics Announces Publication of Data from the Phase 2b IPF Chronic Cough Trial of nalbuphine ER in the Journal of the American Medical Association (JAMA) trevitherapeutics.com ↗
The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. |
| 2025-06-02 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough trevitherapeutics.com ↗
The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6. |
| 2025-05-20 | Trevi Therapeutics | Results Trevi Therapeutics Announces Additional Analyses from Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough trevitherapeutics.com ↗
Patients on Haduvio experienced a statistically-significant improvement (p<0.0001) in the patient-reported Leicester Cough Questionnaire at Day 21 (108 mg BID). |
| 2025-03-10 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough trevitherapeutics.com ↗
Haduvio met the primary endpoint with a statistically-significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001). |
| 2024-12-03 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Topline Results from Human Abuse Potential Study of Oral Nalbuphine trevitherapeutics.com ↗
Topline results demonstrated a statistically significant lower "Drug Liking" for the clinical doses of oral nalbuphine (81mg and 162mg) compared to 6mg IV butorphanol. |
| 2024-09-26 | Trevi Therapeutics | Results Trevi Therapeutics Announces Additional Analyses of Cough Relief Time from Ph2a CANAL Trial Accepted for Oral Presentation at CHEST 2024 trevitherapeutics.com ↗
The results demonstrated a significant increase in relief-of-cough time, reduced cough time, and reduced cough intensity in IPF patients with nalbuphine ER compared with placebo. |
| 2023-10-13 | Trevi Therapeutics | Results Trevi Therapeutics Announces Results from Phase 2b/3 PRISM Open-Label Extension Study of Haduvio™ in Prurigo Nodularis trevitherapeutics.com ↗
The long-term data also supports the continued effectiveness of Haduvio in reducing itch over 52 weeks for the participants who remained in the study. |
| 2023-05-22 | Trevi Therapeutics | Results Trevi Therapeutics Announces Publication of Positive Data from the CANAL Trial in IPF Chronic Cough in NEJM Evidence trevitherapeutics.com ↗
Nalbuphine ER resulted in a rapid and marked reduction in recorded daytime cough among patients suffering from IPF-related cough |
| 2022-10-27 | Trevi Therapeutics | Results Trevi Therapeutics to Present Final Data from Phase 2 Trial of Oral Nalbuphine Extended Release for Chronic Cough in IPF at BTS' Winter Meeting trevitherapeutics.com ↗ |
| 2022-09-19 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Data from Full Set of Subjects in Phase 2 CANAL Trial of Haduvio™ in the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis trevitherapeutics.com ↗
Data from full set of subjects was statistically significant for the primary efficacy endpoint of daytime cough frequency reduction (p<0.0001) |
| 2022-06-29 | Trevi Therapeutics | Results Trevi Therapeutics Reports Positive Results from the Ph2b/3 PRISM Trial of Haduvio™ in the Treatment of Prurigo Nodularis trevitherapeutics.com ↗
Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) (p=0.0157) |
| 2022-03-17 | Trevi Therapeutics | Results Trevi Therapeutics Announces Fourth Quarter and Year End 2021 Financial Results and Business Update trevitherapeutics.com ↗
Interim Analysis in Phase 2 CANAL Trial Showed Primary Efficacy Endpoint of Cough Reduction in Idiopathic Pulmonary Fibrosis was Highly Statistically Significant (p-value less than 0.0001) |
| 2022-02-24 | Trevi Therapeutics | Results Trevi Therapeutics Reports Statistically Significant Result on Interim Analysis from the Ph2 CANAL Trial of Nalbuphine ER in the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis trevitherapeutics.com ↗
The interim analysis (N=26) was statistically significant on the primary efficacy endpoint, demonstrating a 52% placebo-adjusted reduction in the geometric mean percent change in daytime cough events (p<0.0001, conditional power 100%) for Haduvio. |
| 2016-11-15 | Trevi Therapeutics | Results Trevi Therapeutics Selected to Present at the American Society of Nephrology's Kidney Week 2016 Phase 2/3 Data for NalbuphineER in Uremic Pruritus trevitherapeutics.com ↗
We were very pleased with the statistically significant outcome of reduction in itch intensity with Nalbuphine ER in this trial |
| 2016-10-12 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Results from Phase 2 Trial in Prurigo Nodularis trevitherapeutics.com ↗
Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company developing oral Nalbuphine®ER for chronic pruritus conditions, today announced positive results from its Phase 2 trial for the treatment of moderate to severe prurigo nodularis . |
| 2016-04-28 | Trevi Therapeutics | Results Trevi Therapeutics to Present Two Posters at the National Kidney Foundation Spring 2016 Meeting trevitherapeutics.com ↗
This is the largest to date randomized trial in uremic pruritus and it demonstrated the efficacy of Nalbuphine ER for one of the most distressing complications of end stage renal disease, and in the most severe uremic pruritus population. |
| 2015-10-29 | Trevi Therapeutics | Results Trevi Therapeutics Selected to Present at the American Society of Nephrologys Kidney Week 2015 at High-Impact Clinical Trials Session with Phase 2/3 Data for Nalbuphine ER trevitherapeutics.com ↗
We were very pleased with the statistically significant results of Nalbuphine ER in this trial, and look forward to furthering the development of our drug in this condition. |
| 2015-09-10 | Trevi Therapeutics | Results Trevi Therapeutics Announces Positive Results from Phase 2/3 Trial in Uremic Pruritus trevitherapeutics.com ↗
Oral Nalbuphine ER trial achieved statistically significant results on the primary endpoint of reducing itch intensity and also demonstrated sustained duration of effect |
| 2014-11-11 | Trevi Therapeutics | Results Trevi Therapeutics Selected to Exhibit Poster at American Society of Nephrology Kidney Week 2014 trevitherapeutics.com ↗
Also, we believe the proof-of-concept, as measured by the reduction in itch, was compelling and consistent across the patients in the study. |
| 2014-09-09 | Trevi Therapeutics | Results Trevi Therapeutics Selected to Exhibit Poster at 2014 Annual Meeting of the American College of Clinical Pharmacology trevitherapeutics.com ↗
This rigorous study characterized the pharmacokinetics of Nalbuphine ER in renally impaired patients, established that the drug was well tolerated across the entire dose range, and demonstrated the drug is not affected by the dialysis process. |
| 2014-05-09 | Trevi Therapeutics | Results Trevi Therapeutics Exhibits Poster at 2014 Annual Meeting of the Society for Investigative Dermatology trevitherapeutics.com ↗
A dose-dependent decrease in itch was noted in 13 out of 14 patients. |
| 2013-09-25 | Trevi Therapeutics | Results Trevi Therapeutics Presents Data at the 7th World Congress on Itch trevitherapeutics.com ↗
Following nalbuphine administration, a significant reduction in itch (p<0.001) was noted with a 43% reduction in itch at the 10 mg/kg dose and a 51% reduction at the 30 mg/kg dose. |
All press releases naming this drug 34 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 120 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nalbuphine | “A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of...” NCT07868419 ↗116“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 ↗ “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 ↗ “Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets” NCT07671911 ↗ “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 ↗ |
| 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 20214“A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants” NCT07487740 ↗ “Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets” NCT07671911 ↗ “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 ↗ |