Revia, Mysimba(naltrexone)
Contrave, Embeda, Mysimba, Naltrexone, 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 mu-type opioid receptor, delta-type opioid receptor, and kappa-type opioid receptor.
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Commercial
Trade Name
FDA
EMA
Naltrexone, Vivitrol (discontinued: Naltrexone, 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)
Morphine sulfate
+
Naltrexone hydrochloride
Naltrexone hydrochloride
+
Oxycodone hydrochloride
Naltrexone
Bupropion hydrochloride
+
Naltrexone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CONTRAVE | Nalpropion Pharmaceuticals | N-200063 RX | 2014-09-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| contrave | New Drug Application | 2025-05-07 |
| naltrexone | unapproved drug other | 2018-03-19 |
| naltrexone hydrochloride | ANDA | 2025-06-06 |
| naltrexone hyrdochloride | ANDA | 2009-07-21 |
| vivitrol | New Drug Application | 2024-05-22 |
Indications
FDA
EMA
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
532 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 13 | 31 | 24 | 47 | 12 | 122 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 16 | 47 | 32 | 10 | 30 | 116 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 11 | 14 | 16 | 7 | 42 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 2 | 16 | 7 | 4 | 11 | 34 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 7 | 11 | 5 | 10 | 4 | 32 |
| Healthy volunteers/patients | — | — | — | 22 | 2 | — | 2 | 1 | 26 |
| Depression | D003863 | — | F33.9 | 4 | 4 | 4 | 6 | 1 | 18 |
| Overweight | D050177 | — | E66.3 | — | 7 | 9 | 2 | 2 | 17 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 8 | 3 | 3 | 3 | 15 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 4 | 4 | 3 | 5 | — | 15 |
Show 73 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 2 | 11 | 4 | — | 2 | 17 |
| Recurrence | D012008 | — | — | 1 | 5 | 3 | — | 2 | 9 |
| Bulimia | D002032 | — | F50.2 | 2 | 6 | 6 | — | 1 | 9 |
| Addictive behavior | D016739 | EFO_0004347 | — | 1 | 4 | 1 | — | 1 | 6 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 5 | 1 | — | 1 | 6 |
| Binge-eating disorder | D056912 | — | F50.2 | — | 5 | 5 | — | 1 | 6 |
| Analgesia | D000698 | — | — | 3 | — | 1 | — | — | 4 |
| Low back pain | D017116 | — | M54.5 | — | 2 | 1 | — | — | 3 |
| Back pain | D001416 | — | M54 | — | 2 | 1 | — | — | 3 |
| Nerve compression syndromes | D009408 | — | — | — | — | 3 | — | — | 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 | 1 | 4 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | — | — | 1 | 4 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | 1 | 4 | — | — | — | 4 |
| Weight gain | D015430 | — | — | 2 | 2 | — | — | 1 | 3 |
| Fatigue | D005221 | — | R53.83 | — | 2 | — | — | 1 | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 2 | — | — | — | 3 |
| Eczema | D004485 | — | L30.9 | 1 | 2 | — | — | — | 3 |
| Dermatitis | D003872 | — | L30.9 | 1 | 2 | — | — | — | 3 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | 2 | — | — | 1 | 3 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | — | 4 |
| Biological availability | D001682 | — | — | 2 | — | — | — | 1 | 3 |
| Treatment-resistant depressive disorder | D061218 | — | — | 2 | — | — | — | 1 | 3 |
| Pain management | D059408 | — | — | 1 | — | — | — | — | 1 |
| Cognition | D003071 | EFO_0003925 | — | 1 | — | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | 1 | — | — | — | — | 1 |
| Narcotic-related disorders | D000079524 | — | — | 1 | — | — | — | — | 1 |
| Intestinal obstruction | D007415 | — | K56.60 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Neonatal abstinence syndrome | D009357 | EFO_0005799 | P96.1 | — | — | — | — | 1 | 1 |
| High-risk pregnancy | D018566 | — | — | — | — | — | — | 1 | 1 |
| Self concept | D012649 | — | — | — | — | — | — | 1 | 1 |
| Psychological distance | D012929 | — | — | — | — | — | — | 1 | 1 |
| Social psychology | D011593 | — | — | — | — | — | — | 1 | 1 |
| Temporomandibular joint disorders | D013705 | — | M26.6 | — | — | — | — | 1 | 1 |
| Facial pain | D005157 | — | R51.9 | — | — | — | — | 1 | 1 |
| Temporomandibular joint dysfunction syndrome | D013706 | — | — | — | — | — | — | 1 | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
Show 18 more
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 | — |
| ChEMBL ID | CHEMBL19019 |
| ChEBI ID | 7465 |
| PubChem CID | 5360515 |
| DrugBank | DB00704 |
| UNII ID | 5S6W795CQM (ChemIDplus, GSRS) |
Target
Agency Approved
OPRM1
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OPRD1
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OPRK1
OPRK1
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Vivitrol – Alkermes
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Estimated US medical usage
Naltrexone
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Morphine
Total medical expenditures per year (USD, in millions)
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Naltrexone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Contrave
Adverse Events
Top Adverse Reactions
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35,592 adverse events reported
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