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Drug ReportsDoxycycline hyclate
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 mpc, Doxy, Doxycycline, Doxycycline hyclate, Vibramycin (discontinued: Acticlate cap, Atridox, Doryx, Doryx mpc, Doxy-lemmon, Doxycycline, Doxycycline hyclate, Lymepak, Periostat, Vibra-tabs, Vibramycin)
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
ACTICLATEChartwell PharmaceuticalsN-205931 RX2014-07-25
2 products, RLD, RS
DORYXMayne GroupN-050795 RX2013-04-11
2 products, RLD
DORYX MPCMayne GroupN-050795 RX2016-05-20
1 products, RLD
VIBRAMYCINPfizerN-050007 RX1982-01-01
1 products, RLD, RS
Show 11 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acticlateNew Drug Application2017-11-28
doryxNew Drug Application2023-05-30
doryx mpcNew Drug Application2024-04-26
doxycyclate hyclateANDA2024-08-12
doxycyclineANDA2024-12-26
doxycycline doxycycline hyclateANDA2024-12-31
doxycycline hyclateANDA2025-01-03
lymepakNew Drug Application2022-12-20
targadoxANDA2020-07-31
vibramycinANDA2020-12-04
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
434 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424—A49———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Persian gulf syndromeD018923EFO_0007430———1——1
Mycoplasma infectionsD009175————1——1
PleuropneumoniaD011001————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———1———1
Lung neoplasmsD008175HP_0100526C34.90—1———1
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 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—
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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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 86,186 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,791 adverse events reported
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