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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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
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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 |
|---|---|---|---|---|
| ACTICLATE | Chartwell Pharmaceuticals | N-205931 RX | 2014-07-25 | 2 products, RLD, RS |
| DORYX | Mayne Group | N-050795 RX | 2013-04-11 | 2 products, RLD |
| DORYX MPC | Mayne Group | N-050795 RX | 2016-05-20 | 1 products, RLD |
| VIBRAMYCIN | Pfizer | N-050007 RX | 1982-01-01 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acticlate | New Drug Application | 2017-11-28 |
| doryx | New Drug Application | 2023-05-30 |
| doryx mpc | New Drug Application | 2024-04-26 |
| doxycyclate hyclate | ANDA | 2024-08-12 |
| doxycycline | ANDA | 2024-10-28 |
| doxycycline doxycycline hyclate | ANDA | 2024-04-01 |
| doxycycline hyclate | ANDA | 2024-10-18 |
| lymepak | New Drug Application | 2022-12-20 |
| targadox | ANDA | 2020-07-31 |
| vibra-tabs vibramycin calcium vibramycin hyclate vibramycin monohydrate | New Drug Application | 2024-07-16 |
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Agency Specific
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EMA
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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
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Clinical
Clinical Trials
426 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 3 | 7 | 10 | 16 | 11 | 44 |
| Communicable diseases | D003141 | — | — | 3 | 5 | 7 | 8 | 7 | 29 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 4 | 8 | 5 | 8 | 3 | 25 |
| Rosacea | D012393 | — | L71 | 3 | 3 | 4 | 8 | 2 | 20 |
| Sexually transmitted diseases | D012749 | — | A50-A64 | 1 | 1 | 2 | 9 | 4 | 16 |
| Covid-19 | D000086382 | — | — | 3 | 4 | 5 | 3 | 2 | 15 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | 3 | 8 | 2 | 14 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | 5 | 3 | 3 | 4 | 14 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | — | 1 | 2 | 7 | 3 | 13 |
| Erythema chronicum migrans | D015787 | — | A26.0 | — | — | — | 2 | 10 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 6 | 2 | — | 2 | 9 |
| Colorectal neoplasms | D015179 | — | — | — | 6 | 1 | — | 2 | 9 |
| Lymphoma | D008223 | — | C85.9 | — | 4 | 1 | — | — | 5 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 4 | 1 | — | — | 5 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 3 | 2 | — | — | 4 |
| Infarction | D007238 | EFO_0009463 | — | — | 3 | 2 | — | — | 4 |
| Filarial elephantiasis | D004605 | EFO_0007272 | B74.0 | — | 1 | 3 | — | — | 4 |
| Filariasis | D005368 | — | B74 | — | 1 | 3 | — | — | 4 |
| Elephantiasis | D004604 | EFO_0004711 | — | — | 1 | 3 | — | — | 4 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 3 | 2 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | 4 | 5 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | 1 | 3 | — | — | 1 | 5 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | — | — | 1 | 4 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | 3 | — | — | 1 | 4 |
| Eye diseases | D005128 | EFO_0003966 | H44 | 1 | 2 | — | — | 2 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 3 |
| Disease progression | D018450 | — | — | 1 | 1 | — | — | 1 | 3 |
| T-cell lymphoma | D016399 | — | — | 1 | 2 | — | — | — | 3 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | 1 | 3 | — | — | — | 3 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | 2 | — | — | 1 | 3 |
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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 | — | — | — | 2 | 8 |
| Disease | D004194 | EFO_0000408 | R69 | 5 | — | — | — | — | 5 |
| Therapeutic equivalency | D013810 | — | — | 5 | — | — | — | — | 5 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | — | — | 2 | 3 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Hemangioma | D006391 | — | D18.0 | 2 | — | — | — | — | 2 |
| Arteriovenous malformations | D001165 | — | — | 2 | — | — | — | — | 2 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | 1 | — | — | — | — | 1 |
| Elbow tendinopathy | D000070639 | — | M77.0 | 1 | — | — | — | — | 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 encephalitis | D004675 | EFO_1001309 | A84 | — | — | — | — | 4 | 4 |
| Encephalitis | D004660 | HP_0002383 | — | — | — | — | — | 4 | 4 |
| Staphylococcal infections | D013203 | — | A49.01 | — | — | — | — | 4 | 4 |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 3 | 3 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | — | 2 | 2 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 2 | 2 |
| Fistula | D005402 | — | — | — | — | — | — | 2 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 2 | 2 |
| Schistosomiasis haematobia | D012553 | EFO_0007530 | B65.0 | — | — | — | — | 1 | 1 |
| Schistosoma haematobium | D012548 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doxycycline hyclate |
| INN | doxycycline |
| 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-ID | 564-25-0 |
| RxCUI | 1545992 |
| ChEMBL ID | CHEMBL1200567 |
| ChEBI ID | — |
| PubChem CID | 54671203 |
| DrugBank | DB00254 |
| UNII ID | 334895S862 (ChemIDplus, GSRS) |
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5,413 adverse events reported
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