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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Trade Name
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Acticlate, Doryx, Doryx mpc, Vibramycin (generic drugs available since 1982-01-01, discontinued: Acticlate cap, Atridox, Doxy-lemmon, Lymepak, Periostat, Vibra-tabs)
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 | Almirall | N-205931 RX | 2014-07-25 | 2 products, RLD, RS |
| DORYX MPC | Mayne Group | N-050795 RX | 2016-05-20 | 2 products, RLD, RS |
| DORYX | Mayne Group | N-050795 RX | 2005-05-06 | 6 products, RLD |
| VIBRAMYCIN | Mylan | N-050007 RX | 1982-01-01 | 1 products, RLD, RS |
Show 9 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| doryx | New Drug Application | 2020-03-13 |
| doryx mpc | New Drug Application | 2021-06-24 |
| doxycyclate hyclate | ANDA | 2024-01-30 |
| doxycycline | ANDA | 2024-01-09 |
| doxycycline doxycycline hyclate | ANDA | 2023-10-10 |
| doxycycline hyclate | ANDA | 2024-01-30 |
| lymepak | New Drug Application | 2019-05-01 |
| targadox | ANDA | 2020-07-31 |
| vibra-tabs vibramycin calcium vibramycin hyclate vibramycin monohydrate | New Drug Application | 2024-01-22 |
| vibramycin | ANDA | 2010-01-12 |
Indications
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Agency Specific
FDA
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
415 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 vulgaris | D000152 | EFO_0003894 | L70 | 4 | 8 | 4 | 8 | 3 | 24 |
| Rosacea | D012393 | — | L71 | 3 | 2 | 4 | 8 | 2 | 19 |
| Covid-19 | D000086382 | — | U07.1 | 3 | 4 | 5 | 3 | 2 | 15 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | 7 | 4 | 12 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | 4 | 2 | 3 | 4 | 12 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | 2 | 5 | 1 | 9 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | — | — | 2 | 5 | 1 | 8 |
| Sexually transmitted diseases | D012749 | — | A50-A64 | — | 1 | 1 | 3 | 3 | 7 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 2 | 3 | 1 | 6 |
| Lyme disease | D008193 | — | A69.2 | — | — | 2 | 2 | 2 | 6 |
Show 59 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 4 | 1 | — | 2 | 7 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 3 | 1 | — | 2 | 5 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 3 | 2 | — | — | 4 |
| Graves ophthalmopathy | D049970 | EFO_1001466 | — | 1 | 3 | 1 | — | 1 | 4 |
| Surgical wound infection | D013530 | — | — | — | — | 3 | — | — | 3 |
| Filarial elephantiasis | D004605 | EFO_0007272 | B74.0 | — | — | 3 | — | — | 3 |
| Lymphedema | D008209 | HP_0001004 | Q82.0 | — | — | 3 | — | — | 3 |
| Filariasis | D005368 | — | B74 | — | — | 3 | — | — | 3 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 2 | 1 | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | 2 | — | 1 | 3 |
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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 | — | — | 2 | 3 |
| Pelvic inflammatory disease | D000292 | EFO_1001388 | N70-N77 | — | 2 | — | — | 1 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | — | — | 1 | 3 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | 1 | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | — | — | 1 | 2 |
| Anthrax | D000881 | — | A22 | 1 | 1 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | 1 | — | — | 1 | 2 |
| Oral lichen planus | D017676 | — | — | 1 | 1 | — | — | — | 2 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | 1 | — | — | — | 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 | — | — | — | 2 | 8 |
| Therapeutic equivalency | D013810 | — | — | 5 | — | — | — | — | 5 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | 1 | — | — | — | 1 | 2 |
| Arteriovenous malformations | D001165 | — | — | 2 | — | — | — | — | 2 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Elbow tendinopathy | D000070639 | — | M77.0 | 1 | — | — | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | — | — | — | — | 1 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | 1 | — | — | — | — | 1 |
| Cardio-renal syndrome | D059347 | — | — | 1 | — | — | — | — | 1 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | 1 | — | — | — | — | 1 |
Show 8 more
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 |
| Malaria | D008288 | EFO_0001068 | B54 | — | — | — | — | 2 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 2 | 2 |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 1 | 1 |
| Schistosoma haematobium | D012548 | — | — | — | — | — | — | 1 | 1 |
| Aseptic meningitis | D008582 | EFO_1000823 | G03.0 | — | — | — | — | 1 | 1 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | — | 1 | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Tick-borne diseases | D017282 | — | — | — | — | — | — | 1 | 1 |
Show 32 more
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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Safety
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4,281 adverse events reported
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