Phentolamine
Oraverse, Phentolamine, Ryzumvi (phentolamine) is a small molecule pharmaceutical. Phentolamine was first approved as Regitine on 1982-01-01. It is used to treat extravasation of diagnostic and therapeutic materials, malignant hypertension, and necrosis in the USA. The pharmaceutical is active against alpha-1A adrenergic receptor, alpha-1B adrenergic receptor, and alpha-1D adrenergic receptor. In addition, it is known to target alpha-2B adrenergic receptor, alpha-2A adrenergic receptor, and alpha-2C adrenergic receptor.
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Target
Variants
Financial
Trends
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Events Timeline
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YTD
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2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Oraverse, Phentolamine, Ryzumvi (discontinued: Regitine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Phentolamine mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RYZUMVI | Ocuphire Pharma | N-217064 RX | 2023-09-25 | 1 products, RLD, RS |
| ORAVERSE | Septodont | N-022159 RX | 2008-05-09 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| oraverse | New Drug Application | 2018-12-05 |
| phentolamine mesylate | ANDA | 2024-08-19 |
| ryzumvi | New Drug Application | 2024-05-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| necrosis | — | D009336 | — |
| extravasation of diagnostic and therapeutic materials | — | D005119 | — |
| malignant hypertension | EFO_1001031 | D006974 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PHENTOLAMINE MESYLATE, RYZUMVI, FAMYGEN LIFE SCI | |||
| 2026-09-25 | NP | ||
ATC Codes
C: Cardiovascular system drugs
— C04: Peripheral vasodilators
— C04A: Peripheral vasodilators
— C04AB: Imidazoline derivatives, peripheral vasodilators
— C04AB01: Phentolamine
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB36: Phentolamine
HCPCS
Code | Description |
|---|---|
| J2760 | Injection, phentolamine mesylate, up to 5 mg |
Clinical
Clinical Trials
51 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | 1 | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | — | — | 1 | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Phentolamine |
| INN | phentolamine |
| Description | Phentolamine is a substituted aniline that is 3-aminophenol in which the hydrogens of the amino group are replaced by 4-methylphenyl and 4,5-dihydro-1H-imidazol-2-ylmethyl groups respectively. An alpha-adrenergic antagonist, it is used for the treatment of hypertension. It has a role as an alpha-adrenergic antagonist and a vasodilator agent. It is a member of imidazoles, a member of phenols, a tertiary amino compound and a substituted aniline. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ccc(N(CC2=NCCN2)c2cccc(O)c2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 50-60-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL597 |
| ChEBI ID | 8081 |
| PubChem CID | 5775 |
| DrugBank | DB00692 |
| UNII ID | Z468598HBV (ChemIDplus, GSRS) |
Target
Agency Approved
ADRA1A
ADRA1A
ADRA1B
ADRA1B
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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200 adverse events reported
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