Revia, Mysimba(naltrexone)
Contrave, Embeda, Mysimba, Revia, Troxyca, Vivitrol (naltrexone) is a small molecule pharmaceutical. Naltrexone was first approved as Revia on 1984-11-20. It is used to treat alcoholism, drug overdose, and opioid-related disorders in the USA. It has been approved in Europe to treat obesity and overweight. The pharmaceutical is active against delta-type opioid receptor, kappa-type opioid receptor, and mu-type opioid receptor.
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Commercial
Trade Name
FDA
EMA
Vivitrol (generic drugs available since 1998-05-08, discontinued: Revia)
CombinationsContrave (discontinued: Embeda, Troxyca)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bupropion hydrochloride
+
Naltrexone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CONTRAVE | Nalpropion Pharmaceuticals | N-200063 RX | 2014-09-10 | 1 products, RLD, RS |
Morphine sulfate
+
Naltrexone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EMBEDA | Alpharma | N-022321 DISCN | 2009-08-13 | 6 products, RLD |
Hide discontinued
Naltrexone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIVITROL | Alkermes | N-021897 RX | 2006-04-13 | 1 products, RLD, RS |
Naltrexone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REVIA | Teva | N-018932 DISCN | 1984-11-20 | 1 products, RLD |
Hide discontinued
Naltrexone hydrochloride
+
Oxycodone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TROXYCA ER | Mylan | N-207621 DISCN | 2016-08-19 | 6 products |
Hide discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alcoholism | EFO_0003829 | D000437 | F10.1 |
| drug overdose | — | D062787 | — |
| opioid-related disorders | EFO_0005611 | D009293 | F11 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bupropion Hydrochloride / Naltrexone Hydrochloride, Contrave, Nalpropion | |||
| 10231964 | 2034-07-02 | U-1583 | |
| 10828294 | 2034-07-02 | U-1583 | |
| 10835527 | 2034-07-02 | U-1583 | |
| 9633575 | 2033-06-25 | U-1583 | |
| 10403170 | 2033-06-05 | U-1583 | |
| 11139056 | 2033-06-05 | U-1583 | |
| 9248123 | 2032-01-13 | U-1808 | |
| 11033543 | 2031-01-10 | U-1583 | |
| 8916195 | 2030-02-02 | U-1639 | |
| 11324741 | 2029-05-29 | U-1583 | |
| 8088786 | 2029-02-03 | DP | |
| 8318788 | 2027-11-08 | U-1584 | |
| 8722085 | 2027-11-08 | U-1585 | |
| 9125868 | 2027-11-08 | U-1585 | |
| 10307376 | 2027-11-08 | U-1585 | |
| 9107837 | 2027-06-04 | U-1639 | |
| 7375111 | 2025-03-26 | DP | |
| 7462626 | 2024-07-20 | U-1583 | |
| 8815889 | 2024-07-20 | U-1586 | |
| 11278544 | 2024-04-21 | U-1583 | |
| Morphine Sulfate / Naltrexone Hydrochloride, Embeda, Alpharma Pharms | |||
| 8623418 | 2029-11-07 | U-1640 | |
| 7815934 | 2027-12-12 | DP | |
| 7682633 | 2027-06-19 | U-1510 | |
| 7682634 | 2027-06-19 | DP | |
| 8158156 | 2027-06-19 | U-1510 | |
| 8846104 | 2027-06-19 | DP | |
| 8877247 | 2027-06-19 | DP | |
| 8685443 | 2025-07-03 | U-1508 | |
| 8685444 | 2025-07-03 | DP | |
| Naltrexone, Vivitrol, Alkermes | |||
| 7919499 | 2029-10-15 | U-1123, U-1124 | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A08: Antiobesity preparations, excl. diet products
— A08A: Antiobesity preparations, excl. diet products
— A08AA: Centrally acting antiobesity products
— A08AA62: Bupropion and naltrexone
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA56: Oxycodone and naltrexone
— N07: Other nervous system drugs in atc
— N07B: Drugs used in addictive disorders
— N07BB: Drugs used in alcohol dependence
— N07BB04: Naltrexone
HCPCS
Code | Description |
|---|---|
| G2073 | Medication assisted treatment, naltrexone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program) |
| J2212 | Injection, methylnaltrexone, 0.1 mg |
| J2315 | Injection, naltrexone, depot form, 1 mg |
Clinical
Clinical Trials
1244 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 | 4 | 20 | 31 | 62 | 52 | 160 | |
| Pain | D010146 | EFO_0003843 | R52 | 8 | 26 | 30 | 33 | 28 | 116 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 11 | 24 | 22 | 42 | 6 | 101 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 19 | 37 | 24 | 10 | 5 | 81 |
| Analgesia | D000698 | 3 | 2 | 2 | 8 | 28 | 43 | ||
| Acute pain | D059787 | R52 | 5 | 10 | 9 | 12 | 9 | 41 | |
| Neoplasms | D009369 | C80 | 4 | 9 | 12 | 2 | 5 | 31 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 8 | 11 | 9 | 7 | 31 |
| Healthy volunteers/patients | — | 23 | 4 | — | 4 | 1 | 30 | ||
| Chronic pain | D059350 | HP_0012532 | 3 | 8 | 3 | 11 | 5 | 28 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | — | 9 | 3 | — | 1 | 12 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | — | 6 | 9 |
| Tobacco use disorder | D014029 | F17 | 2 | 6 | 2 | — | — | 7 | |
| Overweight | D050177 | E66.3 | — | 1 | 4 | — | 1 | 6 | |
| Binge-eating disorder | D056912 | F50.2 | — | 4 | 4 | — | 1 | 5 | |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 4 | 1 | — | — | 4 |
| Lymphoma | D008223 | C85.9 | — | — | 2 | — | 1 | 3 | |
| Emergencies | D004630 | — | — | 3 | — | — | 3 | ||
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | — | 1 | — | 1 | 3 |
| Borderline personality disorder | D001883 | HP_0012076 | F60.3 | — | 1 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 4 | — | — | 1 | 5 | |
| Inflammation | D007249 | — | 2 | — | — | 2 | 4 | ||
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 1 | — | — | 2 | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | 2 | — | — | 1 | 3 | |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | 2 | — | — | 1 | 3 |
| Treatment-resistant depressive disorder | D061218 | 1 | 1 | — | — | 1 | 3 | ||
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | 2 | 3 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | — | — | — | 3 |
| Diverticulitis | D004238 | EFO_1001460 | K57 | 1 | 1 | — | — | 1 | 2 |
| Recurrence | D012008 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biological availability | D001682 | 2 | — | — | — | 1 | 3 | ||
| Cognition | D003071 | EFO_0003925 | 1 | — | — | — | 1 | 2 | |
| Bulimia | D002032 | F50.2 | 2 | — | — | — | — | 2 | |
| Physiological stress | D013312 | 1 | — | — | — | — | 1 | ||
| Vasoplegia | D056987 | 1 | — | — | — | — | 1 | ||
| Heart arrest | D006323 | EFO_0009492 | I46 | 1 | — | — | — | — | 1 |
| Gastric emptying | D005746 | 1 | — | — | — | — | 1 | ||
| Fatty liver | D005234 | 1 | — | — | — | — | 1 | ||
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | 1 | — | — | — | — | 1 |
| Food addiction | D000073932 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatectomy | D006498 | — | — | — | — | 5 | 5 | ||
| Postoperative complications | D011183 | — | — | — | — | 3 | 3 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 2 | 2 |
| Conduction anesthesia | D000765 | — | — | — | — | 2 | 2 | ||
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 2 | 2 |
| Urinary retention | D016055 | HP_0000016 | R33 | — | — | — | — | 1 | 1 |
| Thoracotomy | D013908 | — | — | — | — | 1 | 1 | ||
| Spine osteoarthritis | D055013 | EFO_1000787 | — | — | — | — | 1 | 1 | |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 1 | 1 |
| Transurethral resection of prostate | D020728 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | NALTREXONE |
| INN | naltrexone |
| Description | Naltrexone is an organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. It has a role as a mu-opioid receptor antagonist, a central nervous system depressant, an environmental contaminant, a xenobiotic and an antidote to opioid poisoning. It is an organic heteropentacyclic compound, a morphinane-like compound and a member of cyclopropanes. It is a conjugate base of a naltrexone(1+). |
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O=C1CC[C@@]2(O)[C@H]3Cc4ccc(O)c5c4[C@@]2(CCN3CC2CC2)[C@H]1O5 |
Identifiers
| PDB | — |
| CAS-ID | 16590-41-3 |
| RxCUI | 7243 |
| ChEMBL ID | CHEMBL19019 |
| ChEBI ID | 7465 |
| PubChem CID | 5360515 |
| DrugBank | DB00704 |
| UNII ID | 5S6W795CQM (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
Vivitrol - Alkermes
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Contrave, Embeda
Adverse Events
Top Adverse Reactions
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1,903 adverse events reported
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