tetracycline
Trade name: tetrex
Approved
Nov 19, 1953
Tetracycline, sold under various brand names, is an antibiotic in the tetracyclines family of medications, used to treat a number of infections, including acne, cholera, brucellosis, plague, malaria, and syphilis. It is available in oral and topical formulations. — Wikipedia
Clinical trial activity
116 trials · 147 clinical orgs · 44 marketing orgs
Earliest trial started Oct 1, 1992 (NCT00591162)
Timeline
1950s
- Nov 19, 1953
Earliest FDA Approval
- Nov 19, 1953
Lederle — NDA Secondary Org
- Nov 19, 1953
American Cyanamid — NDA Secondary Org
- Jan 4, 1954
Pfizer — Marketing Organization
- Sep 17, 1954
Apothecon — Marketing Organization
- Sep 28, 1954
Pharmacia & Upjohn — Marketing Organization
- Nov 23, 1955
Karl Storz — NDA Secondary Org
- Feb 19, 1957
Bristol-Myers — First NDA Organization
- Feb 19, 1957
Bristol-Myers — NDA Organization
- Jun 21, 1957
Par Pharmaceuticals — Marketing Organization
- Oct 8, 1957
Heritage Pharma — NDA Secondary Org
- Oct 8, 1957
Heritage Pharma — Marketing Organization
1960s
- Jul 5, 1963
Teva — Marketing Organization
- Oct 22, 1964
John J. Ferrante — Marketing Organization
- Jul 17, 1968
Mylan — Marketing Organization
- Jul 17, 1968
Aurobindo Pharma — Marketing Organization
1970s
- Jul 13, 1971
Impax Laboratories — Marketing Organization
- May 22, 1972
Roxane Laboratories — Marketing Organization
- Jun 20, 1972
Bristol-Myers — Marketing Organization
- Jun 8, 1973
Warner Chilcott — Marketing Organization
- Dec 24, 1974
Watson Pharmaceuticals — Marketing Organization
- Sep 2, 1977
MM Pharma — Marketing Organization
- Sep 21, 1977
Shire — NDA Secondary Org
- Nov 7, 1977
Hikma — Marketing Organization
1980s
- Feb 7, 1980
Sun Pharmaceuticals — Marketing Organization
- Mar 21, 1985
Superpharm — Marketing Organization
- Aug 12, 1988
Chartwell Pharmaceuticals — Marketing Organization
- Sep 6, 1988
Ani Pharmaceuticals — Marketing Organization
1990s
- Jan 1, 1992
Earliest Phase 2 Sponsor(trial)
- Mar 25, 1994
Schiff Nutrition — NDA Secondary Org
- Aug 15, 1996
Casper Pharma LLC — Marketing Organization
- Aug 15, 1996
Casper Pharma LLC — NDA Secondary Org
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2011
Earliest Phase 1 Sponsor(trial)
- Sep 18, 2018
Amneal Pharmaceuticals — Marketing Organization
- Nov 7, 2018
Esteve Labs — Marketing Organization
- Nov 30, 2018
Ailex Pharmaceuticals — Marketing Organization
2020s
- Mar 3, 2020
Strides Pharma Science — Marketing Organization
- Mar 6, 2023
Bristol-Myers Squibb — Marketing Organization
- Jul 3, 2023
RiconPharma — Marketing Organization
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 4
- Alveolar Bone Grafting · Phase 2
- Arthritis, Rheumatoid · Phase 2
- Bacterial Infections · Phase 4
- Bismuth · Phase 4
- Burns · Phase 2/Phase 3
- Candidiasis · Phase 3
- Candidiasis, Vulvovaginal · Phase 3
- Chalazion · Early Phase 1
- Chlamydia trachomatis · Phase 4
- Chronic Periodontitis · Phase 2
- Colitis, Ulcerative · Phase 2
- Dental Pulp Necrosis · Phase 2
- Dyslipidemias · Phase 3
- Dyspepsia · Phase 4
- Epidermolysis Bullosa · Phase 4
- Exanthema · Phase 2
- Gastritis · Phase 4
- Gastritis, Atrophic · Phase 4
- Healthy Volunteers · Phase 1
- Helicobacter · Phase 3
- Helicobacter Infections · Phase 4
- Helicobacter pylori · Phase 4
- HIV · Phase 3
- Infertility, Female · Phase 3
- Keratoconus · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 2
- Mycoplasma · Phase 4
- Osteoporosis · Phase 4
- Peptic Ulcer · Phase 4
- Periodontitis · Phase 3
- Pleural Effusion, Malignant · Phase 1
- Post-Lyme Disease Syndrome · Phase 2
- Sex · Phase 4
- Sprains and Strains · Phase 3
- Stomach Neoplasms · Phase 4
- Stomach Ulcer · Phase 4
- Stomatitis, Aphthous · Early Phase 1
- Trachoma · Phase 4
- Trichiasis · Phase 4
- Urethritis · Phase 4
- Uterine Cervicitis · Phase 4
- Vaginosis, Bacterial · Phase 3
Mechanism of action
- Bacterial 70S ribosomeINHIBITOR
Bacterial 70S ribosome inhibitor
16s RRNA
- 30S ribosomal protein S2 (rpsB) ↗
- 50S ribosomal protein L4 (rplD) ↗
- 30S ribosomal protein S15 (rpsO) ↗
- 30S ribosomal protein S16 (rpsP) ↗
- 30S ribosomal protein S17 (rpsQ) ↗
- 30S ribosomal protein S18 (rpsR) ↗
- 30S ribosomal protein S19 (rpsS) ↗
- 30S ribosomal protein S20 (rpsT) ↗
- 30S ribosomal protein S21 (rpsU) ↗
- 30S ribosomal protein S3 (rpsC) ↗
- 30S ribosomal protein S4 (rpsD) ↗
- 30S ribosomal protein S5 (rpsE) ↗
- 30S ribosomal protein S6 (rpsF) ↗
- 30S ribosomal protein S7 (rpsG) ↗
- 30S ribosomal protein S8 (rpsH) ↗
- 30S ribosomal protein S9 (rpsI) ↗
- 50S ribosomal protein L35 (rpmI) ↗
- 50S ribosomal protein L36 2 (ykgO) ↗
- 50S ribosomal protein L36 (rpmJ) ↗
- 50S ribosomal protein L3 (rplC) ↗
- 50S ribosomal protein L5 (rplE) ↗
- 50S ribosomal protein L6 (rplF) ↗
- 50S ribosomal protein L7/L12 (rplL) ↗
- 30S ribosomal protein S1 (rpsA) ↗
- 30S ribosomal protein S10 (rpsJ) ↗
- 30S ribosomal protein S11 (rpsK) ↗
- 30S ribosomal protein S12 (rpsL) ↗
- 30S ribosomal protein S13 (rpsM) ↗
- 30S ribosomal protein S14 (rpsN) ↗
- 50S ribosomal protein L10 (rplJ) ↗
- 50S ribosomal protein L11 (rplK) ↗
- 50S ribosomal protein L13 (rplM) ↗
- 50S ribosomal protein L14 (rplN) ↗
- 50S ribosomal protein L15 (rplO) ↗
- 50S ribosomal protein L16 (rplP) ↗
- 50S ribosomal protein L17 (rplQ) ↗
- 50S ribosomal protein L18 (rplR) ↗
- 50S ribosomal protein L19 (rplS) ↗
- 50S ribosomal protein L1 (rplA) ↗
- 50S ribosomal protein L20 (rplT) ↗
- 50S ribosomal protein L21 (rplU) ↗
- 50S ribosomal protein L22 (rplV) ↗
- 50S ribosomal protein L23 (rplW) ↗
- 50S ribosomal protein L24 (rplX) ↗
- 50S ribosomal protein L25 (rplY) ↗
- 50S ribosomal protein L27 (rpmA) ↗
- 50S ribosomal protein L28 (rpmB) ↗
- 50S ribosomal protein L29 (rpmC) ↗
- 50S ribosomal protein L2 (rplB) ↗
- 50S ribosomal protein L30 (rpmD) ↗
- 50S ribosomal protein L31 type B (ykgM) ↗
- 50S ribosomal protein L31 (rpmE) ↗
- 50S ribosomal protein L32 (rpmF) ↗
- 50S ribosomal protein L33 (rpmG) ↗
- 50S ribosomal protein L34 (rpmH) ↗
Combination products
helidac
pylera
tetracyn
Approval history
- approvedNov 19, 1953
Chemistry & pharmacology
SMILES
[Ca++].CN(C)[C@H]1[C@@H]2C[C@H]3C(C(=O)C4=C(O)C=CC=C4[C@@]3(C)O)=C(O)[C@]2(O)C(=O)C(C(N)=O)=C1[O-].CN(C)[C@H]5[C@@H]6C[C@H]7C(C(=O)C8=C(O)C=CC=C8[C@@]7(C)O)=C(O)[C@]6(O)C(=O)C(C(N)=O)=C5[O-]- Mol. weight
- 926.931 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- NCATS9ON2SH59JS ↗
- WikipediaTetracycline ↗
- ChEMBLCHEMBL1440 ↗
- ChEMBLCHEMBL1201071 ↗
- NCATSF8VB5M810T ↗
- ChEMBLCHEMBL454950 ↗
- NCATS6B7BK5H33B ↗
- ChEMBLCHEMBL2103929 ↗
Also known as
- (4s,4as,5as,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
- (4s,4as,5as,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
- abramycin
- abramycin
- achromycin
- achromycin
- achromycin
- achromycin v
- achromycin v
- actisite
- actisite
- bristacycline
- bristacycline
- ciclolysine
- cyclopar
- cyclopar
- deschlorobiomycin
- deschlorobiomycin
- e701
- e701
- economycin
- latycin
- limeciclina
- limeciclina
- liquamycin
- liquamycin
- lymecycline
- lymecycline
- lymecycline
- lymecycline
- lymecycline
- lymecycline
- lymecycline
- lymecycline
- lymecyclinum
- lymecyclinum
- mrc375
- mucomycin
- n2-(((+)-5-amino-5-carboxypentylamino)methyl)tetracycline
- n2-(((+)-5-amino-5-carboxypentylamino)methyl)tetracycline
- (+)-n-(5-amino-5-carboxypentylaminomethyl)-4-dimethylamino-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxonaphthacene-2-carboxamide
- (+)-n-(5-amino-5-carboxypentylaminomethyl)-4-dimethylamino-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxonaphthacene-2-carboxamide
- n6-((4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamido)methyl)lysine
- n6-((4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamido)methyl)lysine
- n-lysinomethyltetracycline
- n-lysinomethyltetracycline
- panmycin
- panmycin
- retet
- retet
- robitet
- robitet
- sumycin
- sumycin
- supramycin
- supramycin
- sustamycin
- sustamycin
- tetrabid organon
- tetrachel
- tetrachel
- tetracyclin
- tetracyclin
- tetracycline
- tetracycline
- tetracycline
- tetracycline
- tetracycline
- tetracycline
- tetracycline
- tetracycline
- tétracycline
- tétracycline
- tetracycline hcl
- tetracycline hcl
- tetracycline hcl
- tetracycline hydrochloride
- tetracycline hydrochloride
- tetracycline hydrochloride
- tetracycline hydrochloride
- tetracycline hydrochloride
- tetracycline-l-methylenelysine
- tetracycline-l-methylenelysine
- tetracycline-l-methylenelysine
- tetracycline-l-methylene lysine
- tetracycline-l-methylene lysine
- tetracycline metaphosphate
- tetracycline metaphosphate
- tetracycline metaphosphate
- tetracyclinemethylenelysine
- tetracycline metronidazole
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracycline phosphate complex
- tetracyclinum
- tetracyclinum
- tetracyline
- tetracyn
- tetracyn
- tetralysal 150
- tetralysal 300
- tetramed
- tetramed
- tetrazyklin
- tetrazyklin
- tetrex
- tetrex
- tetrex
- topicycline
- topicycline
- tsiklomitsin
- tsiklomitsin
- vetquamycin
- vetquamycin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07139366 | Phase 4 | Sep 30, 2025 | People's Liberation Army of China |
| NCT07144657 | Phase 2 | Sep 1, 2025 | National Taiwan University |
| NCT06977841 | N/A | Jun 10, 2025 | Fudan University |
| NCT06955104 | Phase 3 | Apr 3, 2025 | JW Pharmaceutical |
| NCT07068607 | Phase 4 | Apr 1, 2025 | People's Liberation Army of China |
| NCT06225570 | Early Phase 1 (Phase 1) | Jan 31, 2025 | Medical University of South Carolina |
| NCT06723197 | Phase 4 | Dec 10, 2024 | Feicheng Municipal People's Hospital, Qilu Hospital of Shandong University, Shandong University, The People's Hospital of Jimo.Qingdao, Zaozhuang Municipal Hospital, Zibo Maternal and Child Health Hospital |
| NCT06299605 | N/A | Nov 27, 2024 | Feicheng Municipal People's Hospital, Shandong University, Zaozhuang Municipal Hospital, Zibo Maternal and Child Health Hospital |
| NCT06561711 | Phase 4 | Aug 21, 2024 | Jiao Tong University |
| NCT06509139 | Phase 4 | Jul 9, 2024 | National Cheng Kung University |
| NCT06351891 | Phase 4 | Apr 30, 2024 | Shandong University |
| NCT06759610 | N/A | Feb 10, 2024 | Minia University |
| NCT06168214 | Phase 4 | Sep 4, 2023 | People's Liberation Army of China |
| NCT05874570 | Phase 4 | Jun 20, 2023 | Jiao Tong University |
| NCT06168084 | Phase 4 | Jun 6, 2023 | People's Liberation Army of China |
| NCT05874544 | Phase 4 | May 16, 2023 | Jiao Tong University |
| NCT05802888 | Phase 4 | Mar 12, 2023 | Central Hospital, Zibo, Peking University, Shandong University, Taierzhuang District People's Hospital, Zhengzhou University |
| NCT05219929 | Phase 2 | Nov 2, 2022 | Johns Hopkins University |
| NCT05431075 | Phase 4 | Jul 31, 2022 | Central Hospital, Zibo, Peking University, Shandong University, Taierzhuang District People's Hospital, Yuncheng Hospital of Traditional Chinese Medicine, Zhengzhou University |
| NCT05432115 | Phase 4 | Jun 15, 2022 | Central Hospital, Zibo, Peking University, Shandong University, Taierzhuang District People's Hospital, Yuncheng Hospital of Traditional Chinese Medicine, Zhengzhou University |
Organizations
Research & Development (147)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shandong University | Academic/Hospital | 17 | 17 | 2 | 2017 |
| Jiao Tong University | Academic/Hospital | 9 | 9 | 1 | 2012 |
| People's Liberation Army of China | Government | 9 | 7 | 2 | 2016 |
| National Taiwan University | Academic/Hospital | 6 | 6 | 3 | 2015 |
| Seoul National University | Academic/Hospital | 6 | 5 | 3 | 2003 |
| Kaohsiung Medical University | Academic/Hospital | 5 | 2 | 2 | 2013 |
| Peking University | Academic/Hospital | 5 | 2 | 2 | 2021 |
| Taichung Veterans General Hospital | Academic/Hospital | 5 | 5 | 1 | 2013 |
| Fudan University | Academic/Hospital | 4 | 4 | 2 | 2021 |
| Central Hospital, Zibo | Academic/Hospital | 3 | 0 | 1 | 2022 |
| Taierzhuang District People's Hospital | Academic/Hospital | 3 | 0 | 1 | 2022 |
| Technion University | Academic/Hospital | 3 | 1 | 2 | 2006 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 2 | 1995 |
| Zhengzhou University | Academic/Hospital | 3 | 0 | 1 | 2022 |
| CJ HealthCare Corp. | For profit | 2 | 1 | 2 | 2014 |
| Feicheng Municipal People's Hospital | Academic/Hospital | 2 | 0 | 2 | 2024 |
| Government of Mexico | Government | 2 | 2 | 2 | 2010 |
| Hallym University | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Heze Municipal 3rd people's hospital | Academic/Hospital | 2 | 0 | 1 | 2021 |
| International Agency for Research on Cancer | Academic/Hospital | 2 | 1 | 2 | 2014 |
Marketing (51)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANGUS | For profit | MKTG | — |
| AbbVie | For profit | NDA2 | Sep 28, 2006 |
| Abbott | For profit | MKTG | — |
| Ailex Pharmaceuticals | For profit | MKTG | Nov 30, 2018 |
| Allergan | For profit | NDA2 | Sep 28, 2006 |
| Alpharma | For profit | MKTG | — |
| American Cyanamid | For profit | NDA2 | Nov 19, 1953 |
| American Home Products | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 18, 2018 |
| Ani Pharmaceuticals | For profit | SYN | Sep 6, 1988 |
| Ani Pharmaceuticals | For profit | MKTG | Sep 6, 1988 |
| Apothecon | For profit | MKTG | Sep 17, 1954 |
| Aurobindo Pharma | For profit | MKTG | Jul 17, 1968 |
| Bausch Health Companies | For profit | MKTG | — |
| Bristol-Myers | For profit | NDA | Feb 19, 1957 |
| Bristol-Myers | For profit | MKTG | Jun 20, 1972 |
| Bristol-Myers Squibb | For profit | MKTG | Mar 6, 2023 |
| Casper Pharma LLC | For profit | MKTG | Aug 15, 1996 |
| Casper Pharma LLC | For profit | NDA2 | Aug 15, 1996 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 12, 1988 |
| Elkins Sinn | For profit | MKTG | — |
| Esteve Labs | For profit | SYN | Nov 7, 2018 |
| Esteve Labs | For profit | MKTG | Nov 7, 2018 |
| Heather Pharma | For profit | MKTG | — |
| Heritage Pharma | For profit | NDA2 | Oct 8, 1957 |
| Heritage Pharma | For profit | MKTG | Oct 8, 1957 |
| Hikma | For profit | MKTG | Nov 7, 1977 |
| Hikma | For profit | SYN | Nov 7, 1977 |
| Impax Laboratories | For profit | MKTG | Jul 13, 1971 |
| John J. Ferrante | For profit | MKTG | Oct 22, 1964 |
| Karl Storz | For profit | NDA2 | Nov 23, 1955 |
| Lederle | For profit | NDA2 | Nov 19, 1953 |
| MM Pharma | For profit | MKTG | Sep 2, 1977 |
| Mylan | For profit | MKTG | Jul 17, 1968 |
| Par Pharmaceuticals | For profit | MKTG | Jun 21, 1957 |
| Pfizer | For profit | SYN | Sep 2, 1955 |
| Pfizer | For profit | MKTG | Jan 4, 1954 |
| Pharmacia & Upjohn | For profit | MKTG | Sep 28, 1954 |
| Proter | For profit | MKTG | — |
| Puracap Pharmaceutical | For profit | MKTG | — |
| RiconPharma | For profit | MKTG | Jul 3, 2023 |
| Roxane Laboratories | For profit | MKTG | May 22, 1972 |
| Schiff Nutrition | For profit | NDA2 | Mar 25, 1994 |
| Shire | For profit | NDA2 | Sep 21, 1977 |
| Solvay | For profit | MKTG | — |
| Strides Pharma Science | For profit | MKTG | Mar 3, 2020 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 7, 1980 |
| Superpharm | For profit | MKTG | Mar 21, 1985 |
| Teva | For profit | MKTG | Jul 5, 1963 |
| Warner Chilcott | For profit | MKTG | Jun 8, 1973 |
| Watson Pharmaceuticals | For profit | MKTG | Dec 24, 1974 |