Doxycycline anhydrous
Doxycycline, 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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Doxycycline, Monodox, Oracea (discontinued: Doxycycline, Vibramycin)
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 |
|---|---|---|---|---|
| MONODOX | Chartwell Pharmaceuticals | N-050641 RX | 1989-12-29 | 4 products, RLD |
| ORACEA | Galderma | N-050805 RX | 2006-05-26 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acticlate | New Drug Application | 2017-11-28 |
| benoxyldoxy 30 kit | unapproved drug other | 2015-10-19 |
| benzodox 30 kit | unapproved drug other | 2015-10-20 |
| benzodox 60 kit | unapproved drug other | 2015-10-16 |
| direct rx | ANDA | 2015-08-04 |
| doryx | 2007-08-02 | |
| doryx mpc | New Drug Application | 2025-04-03 |
| doxy 100 | ANDA | 2021-02-17 |
| doxy 100(tm) doxycycline | ANDA | 2024-01-30 |
| doxycyclate hyclate | ANDA | 2025-02-12 |
Show 12 more
Indications
FDA
EMA
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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
441 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 | 11 | 17 | 11 | 46 |
| Communicable diseases | D003141 | — | — | 3 | 5 | 7 | 9 | 7 | 30 |
| 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 | 10 | 5 | 18 |
| Covid-19 | D000086382 | — | U07.1 | 3 | 4 | 5 | 3 | 2 | 15 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | 3 | 9 | 2 | 15 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | 5 | 3 | 3 | 5 | 15 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | — | 1 | 2 | 8 | 3 | 14 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 2 | 6 | 4 | 1 | 3 | 13 |
Show 104 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 7 | 1 | — | 2 | 10 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 6 | 2 | — | 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 |
Show 53 more
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 | — | 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 | — | E00-E07 | 1 | 2 | — | — | 1 | 3 |
Show 102 more
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 |
| Phototoxic dermatitis | D017484 | — | — | 1 | — | — | — | 1 | 2 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | 1 | — | — | — | — | 1 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 4 | 4 |
| Tick-borne encephalitis | D004675 | EFO_1001309 | A84 | — | — | — | — | 4 | 4 |
| Encephalitis | D004660 | — | — | — | — | — | — | 4 | 4 |
| Staphylococcal infections | D013203 | — | A49.01 | — | — | — | — | 4 | 4 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | — | 2 | 2 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 2 | 2 |
| Fistula | D005402 | — | — | — | — | — | — | 2 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 2 | 2 |
| Mycoplasma pneumoniae | D009177 | — | B96.0 | — | — | — | — | 2 | 2 |
| Dental implantation | D003757 | — | — | — | — | — | — | 2 | 2 |
Show 54 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doxycycline anhydrous |
| 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 | antibiotics (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-ID | 564-25-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1433 |
| ChEBI ID | 50845 |
| PubChem CID | — |
| DrugBank | DB00254 |
| UNII ID | 334895S862 (ChemIDplus, GSRS) |
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Doxycycline – Fortress Biotech
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Doxycycline – Journey Medical
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Estimated US medical usage
Doxycycline anhydrous
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Doxycycline
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Safety
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25,577 adverse events reported
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