Samidorphan
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Samidorphan
- Molecular weight
- 370.45
- Structure (SMILES)
- NC(=O)c1ccc2c(c1O)[C@]13CCN(CC4CC4)[C@H](C2)[C@]1(O)CCC(=O)C3
- alks 33
- ALKS 33
- alks 5461 component samidorphan
- Alks-33
- ALKS-33
- ALKS-5461 COMPONENT SAMIDORPHAN
- ALKS33 (RDC-0313) (1 mg)
- ALKS33 (RDC-0313) (10 mg)
- ALKS33 (RDC-0313) (2.5 mg)
- rdc 0313
- rdc 0313 00
- RDC-0313
- RDC-0313 (ALKS 33)
- RDC-0313-00
- samidorfano
- Samidorfano
- samidorphan
- Samidorphan
- Samidorphan (High Dose)
- Samidorphan (Low Dose)
- Samidorphan (Medium Dose)
- Samidorphan [INN]
- Samidorphan [MI]
- Samidorphan [USAN]
- Samidorphan [WHO-DD]
And 7 more, listed on the interactive page.
- CAS registry numbers
- 852626-89-2
- ChEMBL ID
- CHEMBL426084
- InChIKey
- RYIDHLJADOKWFM-MAODMQOUSA-N
- PubChem compound IDs
- 11667832
- RxNorm IDs (RxCUI)
- 2559612
- FDA ingredient codes (UNII)
- 7W2581Z5L8
- Applicant
- ALKERMES INC
- Approval date
- 28 May 2021
- Application number
- NDA213378
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- samidorphan
- Type
- Synthetic organic
- Drug name stem
- -orphan
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- μ receptor
- Gene symbol
- OPRM1
- Protein identifier
- P35372
- Median affinity
- 10.28
- Affinity units
- pKi
- Action
- Antagonist
- Action type
- Antagonist
- Target
- δ receptor
- Gene symbol
- OPRD1
- Protein identifier
- P41143
- Median affinity
- 8.59
- Affinity units
- pKi
- Action
- Antagonist
- Action type
- Antagonist
- Target
- κ receptor
- Gene symbol
- OPRK1
- Protein identifier
- P41145
- Median affinity
- 9.64
- Affinity units
- pKi
- Mechanism
- Mu opioid receptor antagonist
- Action type
- Antagonist
- Target
- Mu-type opioid receptor
- Protein identifier
- P35372
- Mechanism
- Mu opioid receptor antagonist
- Action type
- Antagonist
- Target
- Mu-type opioid receptor
- Mechanism
- Delta opioid receptor partial agonist
- Action type
- PARTIAL AGONIST
- Target
- Delta-type opioid receptor
- Mechanism
- Kappa opioid receptor partial agonist
- Action type
- PARTIAL AGONIST
- Target
- Kappa-type opioid receptor
- Action type
- Antagonist
- Gene symbol
- OPRM1
- Protein identifier
- P35372
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- PARTIAL AGONIST
- Gene symbol
- OPRD1
- Protein identifier
- P41143
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- PARTIAL AGONIST
- Gene symbol
- OPRK1
- Protein identifier
- P41145
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Feeding and Eating Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005203
- Subject identifier
- D001068
- Condition
- Cocaine-Related Disorders
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0004456
- Subject identifier
- D019970
- Condition
- Schizophrenia
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005090
- Subject identifier
- D012559
- Condition
- Alcoholism
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007079
- Subject identifier
- D000437
- Condition identifier
- EFO_0005203
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009963
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002009
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004456
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005090
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005186
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005451
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007079
- Highest recorded phase
- 2
- NCT00800319
- NCT00981617
- NCT01098435
- NCT01366001
- NCT01903837
- Dose
- 10 mg/10 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Do not divide tablets or combine strengths
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 3
- Polar surface area
- 103.86
- Calculated partition coefficient (ALogP)
- 1.25
- Calculated partition coefficient (XLogP)
- 1.1
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 3
- Heavy atoms
- 27
- Molecular formula
- C21H26N2O4
- Monoisotopic mass
- 370.18925731
- Natural product
- Yes
- Recorded assays
- 3
- Active assays
- 3
Active assay types
- Confirmatory
- Narcotic Antagonists
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In development for (4)
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- Cocaine abuse Phase 1
- Eating disorder Phase 2
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