tea
Approved
Oct 31, 2006
Black tea is a type of tea that is more oxidized than oolong, yellow, white, and green teas. Black tea is generally stronger in flavour than other teas. All five types are made from leaves of the shrub Camellia sinensis, though Camellia taliensis is also rarely used. — Wikipedia
Clinical trial activity
155 trials · 182 clinical orgs · 3 marketing orgs
Earliest trial started Apr 1, 1998 (NCT00003367)
Timeline
1800s
- Jan 1, 1800
Evidence of US Marketing
2000s
- Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
- Oct 31, 2006
Earliest FDA Approval
- Oct 31, 2006
Ani Pharmaceuticals — Marketing Organization
- Oct 31, 2006
Fougera — NDA Secondary Org
- Oct 31, 2006
Ani Pharmaceuticals — NDA Secondary Org
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Barrett Esophagus · Phase 1
- Basal Cell Carcinoma · Phase 2/Phase 3
- Blepharitis · Phase 4
- Breast Neoplasms · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinoma, Verrucous · Phase 4
- Cataract · Phase 2/Phase 3
- Colitis, Ulcerative · Phase 2
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 2
- Condylomata Acuminata · Phase 4
- COVID-19 · Phase 2
- Diabetes Mellitus · Phase 2/Phase 3
- Diabetes Mellitus, Type 2 · Phase 1/Phase 2
- Doping in Sports · Phase 1
- Dry Eye Syndromes · Phase 1/Phase 2
- Dyslipidemias · Phase 3
- Epidermolysis Bullosa Dystrophica · Phase 2
- Esophageal Neoplasms · Phase 3
- Fear · Phase 2/Phase 3
- Fibrosis · Phase 1
- Gingivitis · Phase 3
- Halitosis · Phase 1/Phase 2
- Healthy Volunteers · Phase 2
- HIV Infections · Phase 1
- Hyperlipidemias · Phase 3
- Ichthyosis, Lamellar · Phase 3
- Infections · Phase 2/Phase 3
- Inflammation · Phase 3
- Influenza, Human · Phase 3
- Irritable Bowel Syndrome · Phase 2
- Kidney Failure, Chronic · Phase 2
- Leiomyoma · Phase 3
- Leukemia · Phase 1/Phase 2
- Lichen Planus, Oral · Early Phase 1
- Lung Neoplasms · Phase 3
- Lymphoma, Follicular · Phase 2
- Melanoma · Phase 2
- Metabolic Diseases · Phase 4
- Multiple Myeloma · Phase 2
- Multiple Sclerosis · Phase 2
- Neoplasms · Phase 1
- Obesity · Phase 3
- Osteoporosis · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Overweight · Phase 3
- Papillomavirus Infections · Phase 2
- Pediculus · Phase 4
- Precancerous Conditions · Phase 2
- Prediabetic State · Phase 3
- Prostatic Hyperplasia · Phase 2
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 1/Phase 2
- Respiratory Tract Infections · Phase 2
- SARS-CoV-2 · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Stomach Neoplasms · Phase 3
- Stomatitis · Phase 2
- Tobacco Use Disorder · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Vaginitis · Phase 4
- Warts · Phase 4
Mechanism of action
- Unspecified targetOTHER
Unknown
Mode of action not fully understood; it seems to inhibit some HPV enzymes, and it has some antioxidant properties
- Unspecified targetUnclear
unclear
Approval history
- approvedOct 31, 2006
- approvedJan 1, 1800
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaBlack tea ↗
- NCATSVIF565UC2G ↗
- WikipediaTea ↗
- WikipediaOolong ↗
- WikipediaHibiscus tea ↗
- WikipediaGreen tea ↗
- NCATSW2ZU1RY8B0 ↗
- NCATST432289GYZ ↗
- ChEMBLCHEMBL1201723 ↗
- NCATSGH42T47V24 ↗
- WikipediaTea tree oil ↗
Also known as
- black tea
- black tea extract
- bte
- decaffeinated black tea
- defined green tea catechin extract
- green tea
- green tea
- green tea extract polyphenone e
- green tea polyphenols
- hibiscus tea
- kunecatechins
- kunecatechins
- lipid-lowing tea
- melaleuca oil
- melaleuca oil
- oolong tea
- poly e green tea extract
- sinecatechins
- sinecatechins
- sinecatechins
- sinecatechins
- sinecatechins
- sinecatechins
- sinecatechins
- sinecatechins
- sinetachins
- tea
- tea
- tea extracts
- tea tree oil
- tea tree oil
- tea tree oil
- ti tree oil
- veregen
- veregen
- veregen
- veregen
- yerba mate tea
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06875791 | Phase 1/Phase 2 (Phase 2) | Dec 28, 2025 | Fundacion Clinica Valle del Lili |
| NCT07094035 | N/A | Jul 30, 2025 | Adamas Pharmaceuticals, Inc. |
| NCT06921525 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2025 | Benha University, Tanta University |
| NCT07150533 | N/A | Mar 1, 2025 | Erzurum Technical University |
| NCT06795438 | N/A | Feb 1, 2025 | University of Central Lancashire |
| NCT06740448 | N/A | Jan 31, 2025 | Berkshire Healthcare NHS Foundation Trust, Biotechnology and Biological Sciences Research Council, University of Reading |
| NCT07164079 | N/A | Dec 12, 2024 | Muğla Sıtkı Koçman University |
| NCT06615752 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2024 | Charles Drew University, National Institutes of Health (NIH) |
| NCT06875440 | N/A | Sep 22, 2024 | Islamic Azad University of Tabriz |
| NCT07052890 | N/A | Sep 19, 2024 | The Functional Gut Clinic |
| NCT06628804 | N/A | Aug 1, 2024 | Pusan National University |
| NCT06687824 | N/A | Apr 2, 2024 | Melaka Manipal Medical College |
| NCT06481254 | N/A | Feb 6, 2024 | Bayburt University, Gumushane University, Karadeniz Technical University |
| NCT06971536 | N/A | Dec 10, 2023 | — |
| NCT06229795 | Phase 3 | Nov 7, 2023 | Ain Shams University |
| NCT07002307 | N/A | Oct 17, 2023 | University of Uyo Teaching Hospital |
| NCT05900960 | N/A | May 9, 2023 | University of Copenhagen |
| NCT05858671 | Phase 2 | May 2, 2023 | Queen's University, Belfast |
| NCT05803590 | N/A | May 1, 2023 | Cairo University |
| NCT05364008 | Phase 3 | Dec 1, 2022 | Johns Hopkins University, National Institutes of Health (NIH), University of Chicago, University of Illinois at Chicago, Yale University |
Organizations
Research & Development (182)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 19 | 6 | 3 | 1998 |
| Unilever | For profit | 8 | 6 | 1 | 2012 |
| University of Arizona | Academic/Hospital | 7 | 5 | 3 | 2003 |
| Louisiana State University | Academic/Hospital | 5 | 5 | 2 | 2004 |
| National Center for Complementary and Integrative Health (NCCIH) | Government | 5 | 0 | 3 | 2003 |
| Amorepacific Corporation | For profit | 4 | 3 | 1 | 2016 |
| MediGene | For profit | 4 | 3 | 3 | 2003 |
| Cairo University | Academic/Hospital | 3 | 3 | 3 | 2017 |
| National Institutes of Health (NIH) | Government | 3 | 0 | 3 | 2007 |
| Tel Aviv University | Academic/Hospital | 3 | 2 | 2 | 2008 |
| University of Reading | Academic/Hospital | 3 | 3 | 1 | 2021 |
| British Columbia Cancer Agency | Academic/Hospital | 2 | 2 | 1 | 2006 |
| Centre Hôpital Universitaire Farhat Hached | Academic/Hospital | 2 | 0 | 1 | 2019 |
| Columbia University | Academic/Hospital | 2 | 0 | 2 | 2004 |
| Department of Defense | Government | 2 | 0 | 2 | 2003 |
| Government of France | Government | 2 | 1 | 1 | 2016 |
| Government of Mexico | Government | 2 | 2 | 2 | 2018 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 2 | 1 | 2 | 2011 |
| Liverpool John Moores University | Academic/Hospital | 2 | 1 | 1 | 2016 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 1 | 2005 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ani Pharmaceuticals | For profit | MKTG | Oct 31, 2006 |
| Ani Pharmaceuticals | For profit | NDA2 | Oct 31, 2006 |
| Fougera | For profit | NDA2 | Oct 31, 2006 |
| MediGene | For profit | NDA | — |