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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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 |
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Vasodilation | D014664 | — | — | 2 | — | — | 1 | 1 | 4 |
| Dental anesthesia | D000766 | — | — | — | 1 | 2 | 1 | — | 4 |
| Local anesthesia | D000772 | — | — | — | — | — | 2 | 1 | 3 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | 1 | 1 | 3 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | 1 | 1 | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | 1 | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | — | — | 1 | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | — | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | 1 | — | 1 |
| Eclampsia | D004461 | — | O15 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | 1 | — | 1 | 4 |
| Pathologic dilatation | D004108 | — | — | — | 1 | 3 | — | — | 4 |
| Dilatation | D004106 | — | — | — | 1 | 3 | — | — | 4 |
| Mydriasis | D015878 | — | H57.04 | — | 1 | 3 | — | — | 4 |
| Presbyopia | D011305 | — | H52.4 | — | 1 | 2 | — | — | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | 1 | — | — | 2 |
| Vitamin a deficiency | D014802 | EFO_1001237 | E50 | — | — | 2 | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | — | 1 | — | — | 1 |
| Soft tissue injuries | D017695 | — | — | — | — | 1 | — | — | 1 |
| Acute kidney injury | D058186 | — | N17 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 1 | 2 |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | 1 | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | 1 | — | — | — | 1 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | 1 | — | — | — | 1 |
| Hypesthesia | D006987 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | — | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | 1 | 2 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | — | 1 | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | — | — | — | — | 1 |
| Vasculogenic impotence | D018783 | EFO_1001234 | — | 1 | — | — | — | — | 1 |
| Stem cell transplantation | D033581 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Community-acquired pneumonia | D000098968 | — | — | — | — | — | — | 1 | 1 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
| Preoperative period | D057234 | — | — | — | — | — | — | 1 | 1 |
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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
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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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