Nalbuphine
Nalbuphine (nalbuphine) is a small molecule pharmaceutical. Nalbuphine was first approved as Nubain on 1982-01-01. It is used to treat postoperative pain in the USA. The pharmaceutical is active against mu-type opioid receptor, kappa-type opioid receptor, and delta-type opioid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Nalbuphine (discontinued: Nalbuphine, Nubain)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nalbuphine hci | ANDA | 2025-01-08 |
| nalbuphine hydrochloride | ANDA | 2025-07-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postoperative pain | — | D010149 | G89.18 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2300 | Injection, nalbuphine hydrochloride, per 10 mg |
Clinical
Clinical Trials
141 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 2 | 5 | 2 | 10 | 19 | 36 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 1 | 2 | 2 | 5 | 11 |
| Pruritus | D011537 | — | L29 | 1 | 5 | 5 | 2 | — | 9 |
| Emergence delirium | D000071257 | — | — | 2 | 4 | 3 | 2 | — | 8 |
| Analgesia | D000698 | — | — | — | 1 | — | 2 | 5 | 8 |
| Anesthesia | D000758 | — | — | — | — | — | 1 | 6 | 7 |
| Cesarean section | D002585 | — | — | — | 1 | 1 | 1 | 5 | 7 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | 1 | 2 | 5 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | — | 2 | 2 | 5 |
| Vomiting | D014839 | — | R11.1 | — | 1 | — | 2 | 2 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prurigo | D011536 | — | L28.2 | — | 3 | 3 | — | — | 3 |
| Cleft palate | D002972 | EFO_0003920 | Q35 | — | — | 1 | — | 1 | 2 |
| Digestive system surgical procedures | D013505 | — | — | — | — | 1 | — | 1 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 1 | 1 | — | — | 1 |
| Heart rate | D006339 | EFO_0004326 | — | — | 1 | 1 | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | 1 | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | — | 1 | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | 1 | — | — | 1 |
| T-cell leukemia | D015458 | — | — | — | — | 1 | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative complications | D011183 | — | — | — | 1 | — | — | 1 | 2 |
| Fibrosis | D005355 | — | — | — | 2 | — | — | — | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 2 | — | — | — | 2 |
| Pulmonary fibrosis | D011658 | — | J84.10 | — | 2 | — | — | — | 2 |
| Cough | D003371 | — | R05 | — | 2 | — | — | — | 2 |
| Labor pain | D048949 | — | — | — | 1 | — | — | 1 | 2 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | 1 | — | — | — | 1 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | 1 | — | — | — | 1 |
| Conscious sedation | D016292 | — | — | — | 1 | — | — | — | 1 |
| Epidural anesthesia | D000767 | — | — | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 2 | 2 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | — | — | 2 | 2 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
Show 57 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nalbuphine |
| INN | nalbuphine |
| Description | Nalbuphine is an organic heteropentacyclic compound. It has a role as a mu-opioid receptor antagonist and an opioid analgesic. It derives from a hydride of a morphinan. |
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Oc1ccc2c3c1O[C@H]1[C@@H](O)CC[C@@]4(O)[C@@H](C2)N(CC2CCC2)CC[C@]314 |
Identifiers
| PDB | — |
| CAS-ID | 20594-83-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL895 |
| ChEBI ID | 7454 |
| PubChem CID | 5311304 |
| DrugBank | DB00844 |
| UNII ID | L2T84IQI2K (ChemIDplus, GSRS) |
Target
Agency Approved
OPRM1
OPRM1
OPRK1
OPRK1
OPRD1
OPRD1
Alternate
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Variants
No data
Financial
Revenue by drug
$
€
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Estimated US medical usage
Nalbuphine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,912 documents
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Safety
Black-box Warning
Black-box warning for: Nalbuphine hci, Nalbuphine hydrochloride
Adverse Events
Top Adverse Reactions
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1,023 adverse events reported
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