Overview
Minocycline was first described in the literacture in 1966. It is a second generation tetracycline antibiotic that is active against gram-negative and gram-positive bacteria. Like other semisynthetic tetracyclines, minocycline has modifications to carbons 7-9 on the D ring to generate higher efficacy than previous tetracyclines. Minocycline was granted FDA approval on 30 June 1971.
Indication
Oral and topical minocycline are indicated to treat inflammatory lesions of acne vulgaris. Subgingival microspheres are indicated as an adjunct treatment in the reduction of pocket depth in adults with periodontitis. Oral and intravenous formulations are indicated to treat infections of susceptible microorganisms. These include rickettsiae, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydophila psittaci, Chlamydia trachomatis, Ureaplasma urealyticum, Borrelia recurrentis, Haemophilus ducreyi, Yersinia pestis, Francisella tularensis, Vibrio cholerae, Campylobacter fetus, Brucella species, Bartonella bacilliformis, Klebsiella granulomatis, Escherichia coli, Enterobacter aerogenes, Shigella species, Acinetobacter species, Haemophilus influenzae, and Kelbsiella species.
Associated Conditions
- Bartonellosis
- Brucellosis
- Campylobacter fetus
- Chancroid
- Cholera (Disorder)
- Conjunctivitis, Inclusion
- Granuloma Inguinale
- Lymphogranuloma Venereum
- Nongonococcal urethritis
- Periodontitis
- Plague
- Psittacosis
- Q Fever
- Relapsing Fever
- Respiratory Tract Infections (RTI)
- Rickettsia Infections
- Rickettsialpox
- Rocky Mountain Spotted Fever
- Trachoma
- Tularemia
- Typhus infections
- Inflammatory lesions
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/21 | Phase 4 | Not yet recruiting | |||
2024/09/19 | Phase 4 | Recruiting | Xijing Hospital of Digestive Diseases | ||
2024/08/05 | Not Applicable | Recruiting | |||
2024/07/26 | Phase 4 | Active, not recruiting | Xijing Hospital of Digestive Diseases | ||
2024/03/12 | Phase 4 | ENROLLING_BY_INVITATION | Second Affiliated Hospital of Xi'an Jiaotong University | ||
2024/02/12 | Phase 2 | Not yet recruiting | |||
2024/02/07 | Phase 4 | Recruiting | |||
2024/01/17 | Phase 2 | Recruiting | IRCCS Centro San Giovanni di Dio Fatebenefratelli | ||
2024/01/11 | Phase 2 | Recruiting | Mostafa Bahaa | ||
2023/11/07 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Torrent Pharmaceuticals Limited | 13668-487 | ORAL | 100 mg in 1 1 | 3/22/2022 | |
| Bausch Health US LLC | 99207-462 | ORAL | 135 mg in 1 1 | 9/12/2017 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0314 | ORAL | 100 mg in 1 1 | 4/10/2023 | |
| Aurobindo Pharma Limited | 59651-337 | ORAL | 50 mg in 1 1 | 9/14/2022 | |
| Rebel Distributors Corp. | 21695-693 | ORAL | 50 mg in 1 1 | 5/1/2007 | |
| A-S Medication Solutions | 50090-2579 | ORAL | 100 mg in 1 1 | 4/6/2022 | |
| Par Pharmaceutical, Inc. | 49884-097 | ORAL | 75 mg in 1 1 | 12/18/2014 | |
| Liberty Pharmaceuticals, Inc. | 0440-7805 | ORAL | 100 mg in 1 1 | 9/25/2013 | |
| Strides Pharma Science Limited | 64380-156 | ORAL | 100 mg in 1 1 | 3/31/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-105 | ORAL | 100 mg in 1 1 | 9/22/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PERIOCLINE PERIODONTAL OINTMENT 2% W/W | SIN15172P | OINTMENT | 20mg/g | 2/3/2017 | |
| BORYMYCIN CAPSULE 50MG | SIN15432P | CAPSULE | 50mg | 2/14/2018 | |
| AA PHARMA MINOCYCLINE CAPSULE 50 mg | SIN10160P | CAPSULE | 50 mg | 10/6/1998 | |
| AA PHARMA MINOCYCLINE CAPSULE 100 mg | SIN10155P | CAPSULE | 100 mg | 10/5/1998 | |
| BORYMYCIN CAPSULE 100 mg | SIN10266P | CAPSULE | 100 mg | 10/14/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Minocycline Hydrochloride Tablets | 国药准字H10960326 | 化学药品 | 片剂 | 8/10/2020 | |
| Minocycline Hydrochloride Tablets | 国药准字H10940126 | 化学药品 | 片剂 | 12/30/2019 | |
| Minocycline Hydrochloride Tablets | 国药准字H20044847 | 化学药品 | 片剂 | 7/28/2020 | |
| Minocycline Hydrochloride Tablets | 国药准字H10940262 | 化学药品 | 片剂 | 8/18/2020 | |
| Minocycline Hydrochloride Tablets | 国药准字H10940263 | 化学药品 | 片剂 | 8/18/2020 | |
| Minocycline Hydrochloride Tablets | 国药准字H10940127 | 化学药品 | 片剂 | 12/25/2019 | |
| Minocycline Hydrochloride Tablets | 国药准字H10950316 | 化学药品 | 片剂 | 11/11/2020 | |
| Minocycline Hydrochloride Ointment | H20150106 | 化学药品 | 软膏剂 | 2/20/2020 | |
| Minocycline Hydrochloride Ointment | 国药准字HJ20150106 | 化学药品 | 软膏剂 | 12/13/2024 | |
| Minocycline Hydrochloride Capsules | 国药准字H44020434 | 化学药品 | 胶囊剂 | 4/1/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MINOCYCLINE 100mg (as hydrochloride) tablet bulk (AF) | 77069 | Medicine | A | 12/7/2000 | |
| MINOMYCIN 50 minocycline 50mg (as hydrochloride) tablet blister pack | 47054 | Medicine | A | 12/7/1993 | |
| MINOCYCLINE 50mg (as hydrochloride) tablet bulk (AF) | 77070 | Medicine | A | 12/7/2000 | |
| Mino 50 | 339924 | Medicine | A | 7/21/2020 | |
| Minomycin 100mg (NZ) | 338831 | Medicine | A | 7/2/2020 | |
| AKAMIN 50 minocycline (as hydrochloride) 50mg tablet bottle | 70852 | Medicine | A | 9/1/1999 |
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