Lofexidine
Lofexidine, Lucemyra (lofexidine) is a small molecule pharmaceutical. Lofexidine was first approved as Lucemyra on 2018-05-16. It is used to treat substance withdrawal syndrome in the USA. It is known to target alpha-2B adrenergic receptor, alpha-2A adrenergic receptor, and alpha-2C adrenergic receptor.
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Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| chemically-induced disorders | D064419 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Lofexidine, Lucemyra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lofexidine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUCEMYRA | US WorldMeds | N-209229 RX | 2018-05-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lofexidine | ANDA | 2024-08-21 |
| lofexidine hydrochloride | ANDA | 2024-11-01 |
| lucemyra | New Drug Application | 2024-09-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| substance withdrawal syndrome | EFO_0005800 | D013375 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
40 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | 5 | 4 | 2 | 1 | — | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 9 | 8 | 4 | — | 1 | 20 |
| Addictive behavior | D016739 | EFO_0004347 | — | 1 | — | 1 | — | — | 2 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | — | — | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 2 | — | — | — | 1 | 3 |
| Neonatal abstinence syndrome | D009357 | EFO_0005799 | P96.1 | 2 | — | — | — | — | 2 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | — | — | — | — | 1 |
| Heroin dependence | D006556 | EFO_0004240 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lofexidine |
| INN | lofexidine |
| Description | Lofexidine is a member of imidazoles, a dichlorobenzene, an aromatic ether and a carboxamidine. It has a role as an alpha-adrenergic agonist and an antihypertensive agent. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(Oc1c(Cl)cccc1Cl)C1=NCCN1 |
Identifiers
| PDB | — |
| CAS-ID | 31036-80-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL17860 |
| ChEBI ID | 51368 |
| PubChem CID | 30668 |
| DrugBank | DB04948 |
| UNII ID | UI82K0T627 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ADRA2B
ADRA2B
ADRA2A
ADRA2A
ADRA2C
ADRA2C
Organism
Homo sapiens
Gene name
ADRA2B
Gene synonyms
ADRA2L1, ADRA2RL1
NCBI Gene ID
Protein name
alpha-2B adrenergic receptor
Protein synonyms
ADRA2B adrenergic, alpha-2B-, receptor, Alpha-2 adrenergic receptor subtype C2, alpha-2-adrenergic receptor-like 1, Alpha-2B adrenoceptor, Alpha-2B adrenoreceptor, Alpha-2BAR, G-protein coupled receptor
Uniprot ID
Mouse ortholog
Adra2b (11552)
alpha-2B adrenergic receptor (P30545)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 753 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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142 adverse events reported
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