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Doxycycline hyclate
Acticlate, Doryx, Vibramycin (doxycycline hyclate) is a small molecule pharmaceutical. Doxycycline hyclate 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Acticlate, Doryx, Doryx mpc, Vibramycin (generic drugs available since 1982-01-01, discontinued: Acticlate cap, Atridox, Doxy-lemmon, Lymepak, Periostat, Vibra-tabs)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxycycline hyclate
Tradename
Company
Number
Date
Products
ACTICLATEAlmirallN-205931 RX2014-07-25
2 products, RLD, RS
DORYX MPCMayne GroupN-050795 RX2016-05-20
2 products, RLD, RS
DORYXMayne GroupN-050795 RX2005-05-06
6 products, RLD
VIBRAMYCINMylanN-050007 RX1982-01-01
1 products, RLD, RS
Show 9 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acticlateNew Drug Application2017-11-28
doryx mpcNew Drug Application2023-06-09
doxycyclineANDA2023-06-13
doxylamine succinate and pyridoxine hydrochlorideNDA authorized generic2023-06-15
lymepakNew Drug Application2022-12-20
vibra-tabs vibramycin calcium vibramycin hyclate vibramycin monohydrateNew Drug Application2021-04-27
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 Hyclate, Doryx, Mayne Pharma
94460572034-12-23DPU-918
92956522034-10-23DPU-918
95110312034-10-23DP
87157242028-02-03DP
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
53 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F1437—1111
AlcoholismD000437EFO_0003829F10.112—428
Anxiety disordersD001008EFO_0006788F41.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_0000515461——8
GliomaD005910EFO_0000520—11——1
Non-small-cell lung carcinomaD002289—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2021——24
Opioid-related disordersD009293EFO_0005611F11—3——14
MelanomaD00854522———3
Alcohol-related disordersD019973F1012———3
Pancreatic neoplasmsD010190EFO_0003860C2511———2
Covid-19D000086382U07.1—2———2
Breast neoplasmsD001943EFO_0003869C50—2———2
Macular degenerationD008268EFO_0001365H35.3011———1
Germ cell and embryonal neoplasmsD009373—1———1
FatigueD005221HP_0012378R53.8311———1
Show 2 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C611———12
Substance-related disordersD019966EFO_0003890F131————1
Multiple myelomaD009101C90.01————1
NeoplasmsD009369C801————1
SarcomaD0125091————1
ObesityD009765EFO_0001073E66.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDOXYCYCLINE HYCLATE
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 class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCO.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.Cl.O
Identifiers
PDB—
CAS-ID564-25-0
RxCUI1545992
ChEMBL IDCHEMBL1200567
ChEBI ID—
PubChem CID54671203
DrugBankDB00254
UNII ID334895S862 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 2,423 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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875 adverse events reported
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