Minocycline
Amzeeq, Arestin, Minocin, Minocycline, Minolira, Solodyn, Zilxi (minocycline) is a small molecule pharmaceutical. Minocycline was first approved as Minocin on 1982-01-01. It is used to treat acne vulgaris, anthrax, borrelia infections, chancroid, and cholera amongst others in the USA.
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Trade Name
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Amzeeq, Arestin, Minocin, Minolira, Solodyn, Zilxi (generic drugs available since 1991-12-30, discontinued: Dynacin, Ximino)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Minocycline hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MINOCIN | Bausch Health Companies | N-050649 RX | 1990-05-31 | 2 products, RLD |
| SOLODYN | Bausch Health Companies | N-050808 RX | 2009-07-23 | 5 products, RLD, RS |
| MINOLIRA | Novan | N-209269 RX | 2017-05-08 | 2 products, RS |
| AMZEEQ | Journey Medical | N-212379 RX | 2019-10-18 | 1 products, RLD, RS |
| ZILXI | Journey Medical | N-213690 RX | 2020-05-28 | 1 products, RLD, RS |
| ARESTIN | Orapharma | N-050781 RX | 2001-02-16 | 1 products, RLD, RS |
| MINOCIN | REMPEX | N-050444 RX | 1982-01-01 | 1 products, RLD, RS |
Show 6 discontinued
Labels
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Indications
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Minocycline Hydrochloride, Amzeeq, Journey | |||
| 10398641 | 2037-09-08 | U-2647 | |
| 10849847 | 2037-09-08 | U-2647 | |
| 8865139 | 2030-10-01 | DP | U-1631, U-2647 |
| 8945516 | 2030-10-01 | DP | |
| 8992896 | 2030-10-01 | DP | U-1631, U-2647 |
| 9675700 | 2030-10-01 | DP | U-1631, U-2647 |
| 10086080 | 2030-10-01 | U-2647 | |
| 10137200 | 2030-10-01 | U-2647 | |
| 10213512 | 2030-10-01 | DP | U-1631, U-2647 |
| 10265404 | 2030-10-01 | DP | |
| 10517882 | 2030-10-01 | U-2647 | |
| 10821187 | 2030-10-01 | U-2647 | |
| Minocycline Hydrochloride, Minolira, Epi Hlth | |||
| 11103517 | 2036-04-07 | DP | |
| Minocycline Hydrochloride, Solodyn, Bausch | |||
| 9192615 | 2031-11-17 | DP | |
| 7541347 | 2027-04-02 | U-917 | |
| 7544373 | 2027-04-02 | DP | |
| 7919483 | 2027-03-07 | U-124, U-1078 | |
| 7790705 | 2025-06-24 | U-124, U-1078 | |
| 8252776 | 2025-06-24 | U-124 | |
| 8268804 | 2025-06-24 | U-124, U-1078 | |
| 8722650 | 2025-06-24 | U-1078 | |
| Minocycline Hydrochloride, Minocin, Rempex | |||
| 9084802 | 2031-05-12 | U-282 | |
| 9278105 | 2031-05-12 | U-282 | |
| Minocycline Hydrochloride, Zilxi, Journey | |||
| 10322186 | 2030-10-01 | U-1631 | |
| 10946101 | 2030-10-01 | U-1631 | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB23: Minocycline
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AF: Antiinfectives for treatment of acne
— D10AF07: Minocycline
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA08: Minocycline
HCPCS
Code | Description |
|---|---|
| J2265 | Injection, minocycline hydrochloride, 1 mg |
Clinical
Clinical Trials
288 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 | 3 | 5 | 5 | 6 | 2 | 21 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | 2 | 6 | 3 | 12 |
| Rosacea | D012393 | — | L71 | 2 | 6 | 3 | 1 | — | 11 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 1 | 3 | 3 | 3 | 9 |
| Ischemic stroke | D000083242 | — | — | 1 | 3 | 2 | 2 | 1 | 7 |
| Psychotic disorders | D011618 | — | F20.81 | 2 | 2 | 1 | 1 | — | 5 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 2 | 2 | 1 | 5 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | — | 2 | 3 | — | 5 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 1 | 1 | 1 | — | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | 1 | 1 | — | 4 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 2 | 1 | — | 2 | 5 |
| Pneumothorax | D011030 | HP_0002108 | J93.11 | — | 1 | 3 | — | 2 | 5 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 1 | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | — | 2 | 1 | — | — | 3 |
| Catheter-related infections | D055499 | — | — | — | — | 2 | — | 1 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 2 | — | — | 3 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | 1 | — | 2 | 3 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 1 | 1 | — | — | 3 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | — | 1 | 1 | — | — | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | 1 | — | — | 2 |
Show 18 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 1 | 3 | — | — | 1 | 4 |
| Fragile x syndrome | D005600 | — | Q99.2 | 1 | 1 | — | — | 2 | 4 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 3 | — | — | — | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 3 | — | — | — | 3 |
| Macular edema | D008269 | — | — | 2 | 2 | — | — | 1 | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 1 | — | — | — | 3 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 2 | 1 | — | — | — | 3 |
| Cerebral hemorrhage | D002543 | — | — | 3 | 2 | — | — | — | 3 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 3 | — | — | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | — | — | 1 | 3 |
Show 48 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | 4 | 10 |
| Dental pulp necrosis | D003790 | — | K04.1 | 3 | — | — | — | 1 | 4 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 2 | — | — | — | — | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | — | — | — | 1 | 2 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | 1 | — | — | — | — | 1 |
| Arteriovenous malformations | D001165 | — | — | 1 | — | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | 1 | — | — | — | — | 1 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | 1 | — | — | — | — | 1 |
| Regeneration | D012038 | — | — | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Granuloma annulare | D016460 | — | L92.0 | — | — | — | — | 1 | 1 |
| Fasting | D005215 | EFO_0002756 | — | — | — | — | — | 1 | 1 |
| Gram-negative bacterial infections | D016905 | — | — | — | — | — | — | 1 | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | — | 1 | 1 |
| Affect | D000339 | — | — | — | — | — | — | 1 | 1 |
| Nonvital tooth | D019553 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Minocycline |
| INN | minocycline |
| Description | Minocycline is a tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5. It has a role as an antibacterial drug, an Escherichia coli metabolite and a geroprotector. It is a member of tetracyclines, a tetracenomycin and a tertiary alpha-hydroxy ketone. It is a conjugate acid of a minocycline(1-). It is a tautomer of a minocycline zwitterion. |
| Classification | Small molecule |
| Drug class | antibiotics (tetracycline derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)c1ccc(O)c2c1C[C@H]1C[C@H]3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C2=O |
Identifiers
| PDB | — |
| CAS-ID | 10118-90-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1434 |
| ChEBI ID | 50694 |
| PubChem CID | 54675783 |
| DrugBank | DB01017 |
| UNII ID | FYY3R43WGO (ChemIDplus, GSRS) |
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Zilxi – Fortress Biotech
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Zilxi – Journey Medical
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Minolira – Novan
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Ximino – Fortress Biotech
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Ximino – Journey Medical
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Amzeeq – Fortress Biotech
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Amzeeq – Journey Medical
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Minocin – Melinta Therapeutics /new/
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Estimated US medical usage
Minocycline
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Trends
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Safety
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6,985 adverse events reported
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