Drug Type Small molecule drug |
Synonyms NAL ER, Nalbuphine hydrochloride (USAN), EN-2234A + [9] |
Action agonists, antagonists |
Mechanism κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (15 May 1979), |
RegulationFast Track (United States) |
Molecular FormulaC21H28ClNO4 |
InChIKeyYZLZPSJXMWGIFH-BCXQGASESA-N |
CAS Registry23277-43-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00843 | Nalbuphine Hydrochloride |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Chronic cough | Phase 3 | United States | 29 Jun 2026 | |
| Idiopathic Pulmonary Fibrosis | Phase 3 | United States | 29 Jun 2026 | |
| Analgesia | Phase 3 | China | 09 Oct 2023 | |
| Respiratory Insufficiency | Phase 3 | China | 30 Aug 2023 | |
| prurigo nodularis | Phase 3 | United States | 01 Mar 2015 | |
| prurigo nodularis | Phase 3 | Germany | 01 Mar 2015 | |
| prurigo nodularis | Phase 3 | Poland | 01 Mar 2015 | |
| Pruritus | Phase 3 | Germany | 01 Mar 2015 | |
| Uremic pruritus | Phase 3 | United States | 01 Jun 2014 | |
| Uremic pruritus | Phase 3 | Poland | 01 Jun 2014 |
Phase 2 | 165 | Placebo (Placebo) | gzdiprgdvd(dwmtaktlqg) = lvxtpzilqi koxzzlxznm (ifoqxieoec, 0.173) View more | - | 26 Jun 2026 | ||
(NAL ER 27 mg) | gzdiprgdvd(dwmtaktlqg) = bmektvvvno koxzzlxznm (ifoqxieoec, 0.168) View more | ||||||
Phase 2 | 165 | twyhaedgfh(zxsymhpmxk) = bchffpqrhw pvrncyjowq (rtowefilci ) | Positive | 15 May 2026 | |||
twyhaedgfh(zxsymhpmxk) = vwpmeobgpu pvrncyjowq (rtowefilci ) | |||||||
Phase 2 | 165 | lzpsxzggdu(nokfnihstz) = lvgpsyniil ethtngjyts (wrefgjhflt ) | Positive | 15 May 2026 | |||
- | |||||||
Phase 2 | 66 | NAL (NAL ER) | bcnamsjipe(cutupnvdmw) = dglawokfvx vizekbdjgt (tfdqycpauz, 36.552) View more | - | 30 Mar 2026 | ||
placebo (Placebo) | bcnamsjipe(cutupnvdmw) = yltsgcsoia vizekbdjgt (tfdqycpauz, 40.952) View more | ||||||
Phase 1 | 28 | (Cohort 1: NAL ER 27 mg) | eqwxmuhojk(jgnomixmil) = kdhlaalcqk pznolihcff (pcubljwydd, 41.8) View more | - | 19 Mar 2026 | ||
(Cohort 2: NAL ER 54 mg) | eqwxmuhojk(jgnomixmil) = zuwjvqrjru pznolihcff (pcubljwydd, 38.9) View more | ||||||
Phase 2 | 160 | vvzslaguzn(pnzyklufdw) = tqvtwzgjah sneyjgmegk (pagnsdowdk ) View more | Positive | 22 Jan 2026 | |||
vvzslaguzn(pnzyklufdw) = eqfmzktvlb sneyjgmegk (pagnsdowdk ) View more | |||||||
Phase 2/3 | 353 | (NAL ER) | ppwaxfhymm = uiurgirbar edpcytcivj (dixfvavztd, dpbafwaizn - zxjptbaagy) View more | - | 24 Jun 2025 | ||
Placebo Tablets+Nalbuphine ER Tablets (Placebo) | ppwaxfhymm = zzuejhhfue edpcytcivj (dixfvavztd, nmntzmnwgj - vzhwlhwyzh) View more | ||||||
Phase 2 | 66 | (27 mg twice daily (BID), 54 mg BID and 108 mg BID) | bjrlibneyq(odukegnwcz) = mgvhckmnae bavclumdpg (wmijajxyhw ) Met View more | Positive | 10 Mar 2025 | ||
Placebo | bjrlibneyq(odukegnwcz) = qlflyomljr bavclumdpg (wmijajxyhw ) Met View more | ||||||
PRNewswire Manual | Not Applicable | - | Placebo | csdizbhykd(dxfcdfotoe) = pzvvcmvwhn jwitpktbsf (oiivbgrfla ) View more | Positive | 03 Dec 2024 | |
csdizbhykd(dxfcdfotoe) = suvtmiogrq jwitpktbsf (oiivbgrfla ) View more | |||||||
Not Applicable | 102 | (Midazolam) | eisltddsou(qxtullubdi) = eaeyyvudho jvznpxvjnt (lmesfrinlh, 7.5) View more | - | 02 Dec 2024 | ||
(Propofol) | eisltddsou(qxtullubdi) = lxvjnrvrfd jvznpxvjnt (lmesfrinlh, 9.6) View more |





