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Drug ReportsPhentolamine
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
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
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
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
RYZUMVIOcuphire PharmaN-217064 RX2023-09-25
1 products, RLD, RS
ORAVERSESeptodontN-022159 RX2008-05-09
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
oraverseNew Drug Application2018-12-05
phentolamine mesylateANDA2024-08-19
ryzumviNew Drug Application2024-05-31
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
PHENTOLAMINE MESYLATE, RYZUMVI, FAMYGEN LIFE SCI
2026-09-25NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Phentolamine Mesylate, Ryzumvi, Famygen Life Sci
114000772039-10-25U-3804
97955602034-01-31DP
102789182034-01-31DP
107728292034-01-31DP
110902612034-01-31DP
118448582034-01-31DP
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 myelomaD009101—C90.0———1—1
Plasma cell neoplasmsD054219—————1—1
Neoplasm metastasisD009362EFO_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 namePhentolamine
INNphentolamine
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(N(CC2=NCCN2)c2cccc(O)c2)cc1
Identifiers
PDB—
CAS-ID50-60-2
RxCUI—
ChEMBL IDCHEMBL597
ChEBI ID8081
PubChem CID5775
DrugBankDB00692
UNII IDZ468598HBV (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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,134 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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186 adverse events reported
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