Samidorphan
Lybalvi (samidorphan) is a small molecule pharmaceutical. Samidorphan was first approved as Lybalvi on 2021-05-28. It is used to treat bipolar disorder and schizophrenia in the USA. It is known to target delta-type opioid receptor, kappa-type opioid receptor, and mu-type opioid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Combinations
Lybalvi
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lybalvi | New Drug Application | 2025-02-28 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OLANZAPINE / SAMIDORPHAN L-MALATE, LYBALVI, ALKERMES INC | |||
| 2026-05-28 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Olanzapine / Samidorphan L-Malate, Lybalvi, Alkermes Inc | |||
| 11707466 | 2041-11-12 | DP | |
| 8778960 | 2032-02-13 | U-3136, U-3137 | |
| 9119848 | 2031-08-30 | DP | |
| 9126977 | 2031-08-23 | DP | U-3136, U-3137 |
| 9517235 | 2031-08-23 | U-3138, U-3139 | |
| 10300054 | 2031-08-23 | DP | U-3140, U-3141 |
| 10716785 | 2031-08-23 | U-3136, U-3137 | |
| 11185541 | 2031-08-23 | U-3140 | |
| 11241425 | 2031-08-23 | U-3137 | |
| 11351166 | 2031-08-23 | U-3140, U-3141 | |
| 11793805 | 2031-08-23 | U-3734 | |
| 7262298 | 2025-11-23 | DP | |
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 2 | 8 | — | — | 11 |
| Depression | D003863 | — | F33.9 | 1 | 1 | 6 | — | — | 7 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 6 | — | — | 7 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 1 | 6 | — | — | 7 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | 4 | — | — | 5 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | 2 | — | — | 2 |
| Body weight | D001835 | EFO_0004338 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | 2 | — | — | — | 3 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 1 | — | — | — | 1 |
| Bulimia | D002032 | — | F50.2 | — | 1 | — | — | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | 1 | — | — | — | 1 |
| Binge-eating disorder | D056912 | — | F50.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | — | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Samidorphan |
| INN | samidorphan |
| Description | Samidorphan is a member of phenanthrenes. |
| Classification | Small molecule |
| Drug class | narcotic antagonists/agonists (morphinan derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)c1ccc2c(c1O)[C@]13CCN(CC4CC4)[C@H](C2)[C@]1(O)CCC(=O)C3 |
Identifiers
| PDB | — |
| CAS-ID | 852626-89-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL426084 |
| ChEBI ID | — |
| PubChem CID | 11667832 |
| DrugBank | DB12543 |
| UNII ID | 7W2581Z5L8 (ChemIDplus, GSRS) |
Target
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Lybalvi – Alkermes
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 350 documents
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Safety
Black-box Warning
Black-box warning for: Lybalvi
Adverse Events
Top Adverse Reactions
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1,250 adverse events reported
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