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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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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Combinations
Lybalvi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olanzapine
+
Samidorphan l-malate
Tradename
Company
Number
Date
Products
LYBALVIAlkermesN-213378 RX2021-05-28
4 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
lybalviNew Drug Application2021-05-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bipolar disorderEFO_0000289D001714F30.9
schizophreniaEFO_0000692D012559F20
Agency Specific
FDA
EMA
Expiration
Code
OLANZAPINE / SAMIDORPHAN L-MALATE, LYBALVI, ALKERMES INC
2026-05-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Olanzapine / Samidorphan L-Malate, Lybalvi, Alkermes Inc
87789602032-02-13U-3136, U-3137
91198482031-08-30DP
91269772031-08-23DPU-3136, U-3137
95172352031-08-23U-3138, U-3139
103000542031-08-23DPU-3140, U-3141
107167852031-08-23U-3136, U-3137
111855412031-08-23U-3140
112414252031-08-23U-3137
113511662031-08-23U-3140, U-3141
72622982025-11-23DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CholangiocarcinomaD018281C22.1131——5
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8043———6
GlioblastomaD005909EFO_000051511———2
AchondroplasiaD000130Q77.4—2———2
GliomaD005910EFO_000052021———2
MelanomaD008545—1———1
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11———1
Renal cell carcinomaD00229211———1
Pancreatic ductal carcinomaD02144111———1
Pancreatic neoplasmsD010190EFO_0003860C2511———1
Colonic neoplasmsD003110C1811———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder neoplasmsD001749C672———13
Breast neoplasmsD001943EFO_0003869C501————1
Triple negative breast neoplasmsD0647261————1
Uterine cervical neoplasmsD0025831————1
Transitional cell carcinomaD0022951————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSAMIDORPHAN
INNsamidorphan
Description
Samidorphan is a member of phenanthrenes.
Classification
Small molecule
Drug classnarcotic 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-ID852626-89-2
RxCUI—
ChEMBL IDCHEMBL426084
ChEBI ID—
PubChem CID11667832
DrugBankDB12543
UNII ID7W2581Z5L8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
OPRD1
OPRD1
OPRK1
OPRK1
OPRM1
OPRM1
Organism
Homo sapiens
Gene name
OPRD1
Gene synonyms
OPRD
NCBI Gene ID
4985
Protein name
delta-type opioid receptor
Protein synonyms
D-OR-1, delta opioid receptor 1, DOR-1
Uniprot ID
P41143
Mouse ortholog
Oprd1 (18386)
delta-type opioid receptor (P32300)
Variants
Clinical Variant
No data
Financial
Lybalvi - Alkermes
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 207 documents
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Safety
Black-box Warning
Black-box warning for: Lybalvi
Adverse Events
Top Adverse Reactions
Mock data
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19 adverse events reported
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