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Drug ReportsBetamethasone
Betamethasone
Beta-val, Betamethasone, Betamethasone /, Betamethasone / Betamethasone, Celestone, Dermabet, Diprolene, Enstilar, Sernivo, Taclonex, Uticort, Valnac, Wynzora (betamethasone) is a small molecule pharmaceutical. Betamethasone was first approved as Celestone on 1982-01-01. It is used to treat atopic dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, and inflammation amongst others in the USA. The pharmaceutical is active against glucocorticoid 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
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Beta-val, Betamethasone, Dermabet, Diprolene, Sernivo, Valnac (discontinued: Alphatrex, Beta-val, Betaderm, Betamethasone, Betatrex, Celestone, Diprolene, Diprosone, Luxiq, Uticort, Valisone)
Combinations
Betamethasone betamethasone, Calcipotriene betamethasone, Celestone soluspan, Clotrimazole betamethasone, Enstilar, Taclonex, Wynzora (discontinued: Calcipotriene betamethasone, Calcipotriene bethamethasone, Lotrisone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Betamethasone dipropionate
+
Calcipotriene
Tradename
Company
Number
Date
Products
ENSTILARLEO PharmaN-207589 RX2015-10-16
1 products, RLD, RS
TACLONEXLEO PharmaN-021852 RX2006-01-09
1 products, RLD, RS
TACLONEXLEO PharmaN-022185 RX2008-05-09
1 products, RLD, RS
WYNZORAMC2 TherapeuticsN-213422 RX2020-07-20
1 products, RLD, RS
Betamethasone valerate
Tradename
Company
Number
Date
Products
BETA-VALCosette Pharmaceuticals N-018642 RX1983-03-24
1 products
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018861 RX1983-08-31
1 products, RLD, RS
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018865 RX1983-08-31
1 products, RLD, RS
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018866 RX1983-08-31
1 products, RLD, RS
Show 11 discontinued
Betamethasone acetate
+
Betamethasone sodium phosphate
Tradename
Company
Number
Date
Products
CELESTONE SOLUSPANOrganonN-014602 RX1982-01-01
1 products, RLD, RS
Betamethasone dipropionate
Tradename
Company
Number
Date
Products
BETAMETHASONE DIPROPIONATEFougera PharmaceuticalsN-019137 RX1984-06-26
1 products, RLD, RS
BETAMETHASONE DIPROPIONATEFougera PharmaceuticalsN-019141 RX1984-09-04
1 products, RLD, RS
DIPROLENEOrganonN-018741 RX1983-07-27
1 products, RLD, RS
SERNIVOPrimus PharmaceuticalsN-208079 RX2016-02-05
1 products, RLD, RS
Show 11 discontinued
Betamethasone dipropionate
+
Clotrimazole
Tradename
Company
Number
Date
Products
LOTRISONEMerck & CoN-020010 DISCN2000-12-08
1 products, RLD
LOTRISONEOrganonN-018827 DISCN1984-07-10
1 products, RLD
Hide discontinued
Betamethasone
Tradename
Company
Number
Date
Products
CELESTONEMerck & CoN-014215 DISCN1982-01-01
1 products
CELESTONEMerck & CoN-012657 DISCN1982-01-01
1 products
CELESTONEMerck & CoN-014762 DISCN1982-01-01
1 products
Hide discontinued
Betamethasone sodium phosphate
Tradename
Company
Number
Date
Products
CELESTONEMerck & CoN-017561 DISCN1982-01-01
1 products, RLD
Hide discontinued
Betamethasone benzoate
Tradename
Company
Number
Date
Products
UTICORTPfizerN-016998 DISCN1982-01-01
1 products
UTICORTPfizerN-017244 DISCN1982-01-01
1 products
UTICORTPfizerN-017528 DISCN1982-01-01
1 products
UTICORTPfizerN-018089 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amolg aunapproved drug other2019-03-15
beta 1 kitANDA2024-10-17
betalido kitunapproved drug other2024-12-31
betaloan suikunapproved drug other2024-12-31
betamethasone dipropionate 0.05% / niacinamide 4%unapproved drug other2019-05-20
betamethasone clotrimazoleANDA2009-10-27
betamethasone dipropionateANDA2025-02-07
betamethasone dipropionate 0.05% / minoxidil 5%unapproved drug other2019-04-24
betamethasone dipropionate 0.05% / minoxidil 5% / niacinamide 2% / pentoxifylline 0.5%unapproved drug other2019-05-08
betamethasone dipropionate betamethasone dipropionate2007-10-09
Show 22 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2
116969192039-03-18DP
102652652027-09-27DP
Betamethasone Dipropionate / Calcipotriene, Enstilar, Leo Pharma As
91197812031-06-10DPU-1761, U-2627
95662862031-06-10DP
101306402031-06-10DP
106176982031-06-10DP
106609082031-06-10DPU-2627
106823642031-06-10DP
106881082031-06-10U-2627
107167992031-06-10DP
Betamethasone Dipropionate, Sernivo, Primus Pharms
93644852030-08-31DPU-1858
94336302030-08-31DPU-1858
94399112030-08-31DPU-1858
96559072030-08-31DPU-1858
97758512030-08-31DPU-1858
98779742030-08-31DPU-1858
101791372030-08-31DPU-1858
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA04: Betamethasone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA05: Betamethasone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AC: Corticosteroids, potent (group iii)
— D07AC01: Betamethasone
— D07B: Corticosteroids, combinations with antiseptics
— D07BC: Corticosteroids, potent, combinations with antiseptics
— D07BC01: Betamethasone and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CC: Corticosteroids, potent, combinations with antibiotics
— D07CC01: Betamethasone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XC: Corticosteroids, potent, other combinations
— D07XC01: Betamethasone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB01: Betamethasone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD06: Betamethasone
— R03: Drugs for obstructive airway diseases
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA04: Betamethasone
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA06: Betamethasone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB04: Betamethasone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA05: Betamethasone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB04: Betamethasone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA07: Betamethasone
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA03: Betamethasone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA06: Betamethasone and antiinfectives
HCPCS
Code
Description
J0702
Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg
J7624
Betamethasone, inhalation solution, compounded product, administered through dme, unit dose form, per milligram
Clinical
Clinical Trials
411 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L401————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBetamethasone
INNbetamethasone
Description
Betamethasone is a glucocorticoid, a 20-oxo steroid, a 21-hydroxy steroid, a 17alpha-hydroxy steroid, a fluorinated steroid, an 11beta-hydroxy steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It has a role as an anti-inflammatory drug, an anti-asthmatic agent and an immunosuppressive agent. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CO
Identifiers
PDB—
CAS-ID378-44-9
RxCUI—
ChEMBL IDCHEMBL632
ChEBI ID3077
PubChem CID9782
DrugBankDB00443
UNII ID9842X06Q6M (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Wynzora – Novan
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Betamethasone – Organon
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Diprosone – Organon
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Estimated US medical usage
Betamethasone
Total medical expenditures per year (USD, in millions)
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Betamethasone
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Calcipotriene
Total medical expenditures per year (USD, in millions)
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Betamethasone
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Clotrimazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,609 documents
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Safety
Black-box Warning
Black-box warning for: Bl-c kit, Bl-contrast, Marbeta 25 kit, Marbeta l kit
Adverse Events
Top Adverse Reactions
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14,688 adverse events reported
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