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Doxycycline anhydrous
Monodox, Oracea, Vibramycin (doxycycline anhydrous) is a small molecule pharmaceutical. Doxycycline anhydrous was first approved as Vibramycin on 1982-01-01. It is used to treat anthrax, bacterial pneumonia, campylobacter infections, cholera, and granuloma inguinale amongst others in the USA.
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COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Monodox, Oracea, Vibramycin (generic drugs available since 1988-03-09, discontinued: Doxychel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxycycline
Tradename
Company
Number
Date
Products
MONODOXChartwell PharmaceuticalsN-050641 RX1989-12-29
4 products, RLD
ORACEAGaldermaN-050805 RX2006-05-26
1 products, RLD, RS
VIBRAMYCINMylanN-050006 RX1982-01-01
1 products, RLD, RS
Doxycycline calcium
Tradename
Company
Number
Date
Products
VIBRAMYCINMylanN-050480 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
doxycyclineANDA2023-06-13
monodoxNew Drug Application2017-04-26
oracea New Drug Application2017-08-01
vibra-tabs vibramycin calcium vibramycin hyclate vibramycin monohydrateNew Drug Application2021-07-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anthrax—D000881A22
bacterial pneumoniaEFO_1001272D018410J15.9
campylobacter infectionsEFO_0007190D002169—
cholera—D002771A00
granuloma inguinaleEFO_0007291D006100A58
mycoplasma infections—D009175—
plagueEFO_0007481D010930A20
pleural effusion—D010996J90
psittacosisEFO_0007410D009956A70
relapsing fever—D012061A68
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Doxycycline, Oracea, Galderma Labs Lp
77495322027-12-19DPU-1063
82067402025-12-24DPU-925
83944052024-04-07DPU-925
83944062024-04-07DPU-925
84703642024-04-07DPU-925
87094782024-04-07U-1063
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB22: Doxycycline
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA02: Doxycycline
HCPCS
No data
Clinical
Clinical Trials
316 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne vulgarisD000152EFO_0003894L703648119
RosaceaD012393L713148117
Covid-19D000086382U07.11353213
InfectionsD007239EFO_0000544———6410
Periodontal diseasesD010510K05.6—32239
Chlamydia infectionsD002690EFO_0007205A74.9—125—8
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9——2316
SyphilisD013587EFO_0007504A53.9——24—6
Lyme diseaseD008193A69.2——2215
Erythema chronicum migransD015787A26.0———145
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AmyloidosisD000686EFO_1001875E85131—14
Chronic periodontitisD055113EFO_0006343K05.3—32——4
Graves ophthalmopathyD049970EFO_1001466131—14
Filarial elephantiasisD004605EFO_0007272B74.0——3——3
LymphedemaD008209Q82.0——3——3
FilariasisD005368B74——3——3
TuberculosisD014376EFO_0000774A15-A19—21——3
Heart failureD006333EFO_0003144I50—11——2
Ventricular remodelingD020257—11——2
St elevation myocardial infarctionD000072657—11——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179—2——13
Ulcerative colitisD003093EFO_0000729K51—2——13
Pelvic inflammatory diseaseD000292EFO_1001388N70-N77—1——12
Non-small-cell lung carcinomaD002289—1——12
AnthraxD000881A2211———2
Pancreatic neoplasmsD010190EFO_0003860C25—1——12
Breast neoplasmsD001943EFO_0003869C5011———2
T-cell lymphoma cutaneousD016410C84.A11———2
Atopic dermatitisD003876EFO_0000274L20—2———2
MansonelliasisD008368EFO_0007357B74.4—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6———28
Therapeutic equivalencyD0138105————5
Tennis elbowD013716EFO_1001896M77.11———12
Arteriovenous malformationsD0011652————2
Elbow tendinopathyD000070639M77.01————1
Coronavirus infectionsD018352EFO_0007224B34.21————1
Severe acute respiratory syndrome-related coronavirusD045473NCBITaxon_2278591————1
Cardio-renal syndromeD0593471————1
Intracranial aneurysmD002532EFO_0003870I67.11————1
Cavernous hemangiomaD006392D18.01————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tick-borne encephalitisD004675EFO_1001309A84————22
Rheumatoid arthritisD001172EFO_0000685M06.9————22
MalariaD008288EFO_0001068B54————11
Mycoplasma pneumoniaD011019EFO_0007387J15.7————11
Aseptic meningitisD008582EFO_1000823G03.0————11
Staphylococcus aureusD013211NCBITaxon_1280————11
Female infertilityD007247EFO_0008560N97————11
Liver cirrhosisD008103EFO_0001422K74.0————11
InfertilityD007246EFO_0000545————11
Diet therapyD004035————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDOXYCYCLINE ANHYDROUS
INNdoxycycline
Description
Doxycycline is tetracycline in which the 5beta-hydrogen is replaced by a hydroxy group, while the 6alpha-hydroxy group is replaced by hydrogen. A semi-synthetic tetracycline antibiotic, it is used to inhibit bacterial protein synthesis and treat non-gonococcal urethritis and cervicitis, exacerbations of bronchitis in patients with chronic obstructive pulmonary disease (COPD), and adult periodontitis. It has a role as an antibacterial drug, an antimalarial, a geroprotector, an anti-inflammatory agent and an immunomodulator.
Classification
Small molecule
Drug classantibiotics (tetracycline derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@H]1c2cccc(O)c2C(=O)C2=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@@H]3[C@@H](O)[C@@H]21
Identifiers
PDB—
CAS-ID564-25-0
RxCUI1545992
ChEMBL IDCHEMBL1433
ChEBI ID50845
PubChem CID54671203
DrugBankDB00254
UNII ID334895S862 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Doxycycline - Fortress Biotech, Inc.
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Doxycycline - Journey Medical
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 72,122 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,260 adverse events reported
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