glutathione
Trade name: Furadantin
Approved
Dec 7, 1953
Glutathione is an organic compound made of the amino acids glutamate, cysteine, and glycine. It is an antioxidant in plants, animals, fungi, and some bacteria and archaea. Glutathione is capable of preventing damage to important cellular components caused by sources such as reactive oxygen species, free radicals, peroxides, lipid peroxides, and heavy metals. It is a tripeptide with a gamma peptide linkage between the carboxyl group of the glutamate side chain and cysteine. The carboxyl group of the cysteine residue is attached by normal peptide linkage to glycine. — Wikipedia
Clinical trial activity
50 trials · 71 clinical orgs · 34 marketing orgs
Earliest trial started Feb 1, 2002 (NCT00910442)
Timeline
1950s
- Dec 7, 1953
Earliest FDA Approval
- Dec 7, 1953
Strides Pharma Science — Marketing Organization
- Dec 7, 1953
DAVA Pharmaceuticals — Marketing Organization
- Aug 10, 1959
Hospira — Marketing Organization
1970s
- Sep 5, 1979
Bristol-Myers — Marketing Organization
1980s
- Oct 28, 1981
Nestle — First NDA Organization
- Oct 28, 1981
Alcon — NDA Secondary Org
- Oct 28, 1981
Nestle — NDA Secondary Org
- Oct 28, 1981
Nestle — NDA Organization
- Feb 14, 1985
Bristol-Myers Squibb — Marketing Organization
- May 9, 1986
Norbrook — Marketing Organization
- Jun 13, 1986
Abraxis — Marketing Organization
- Sep 16, 1986
West-Ward Pharmaceutical — Marketing Organization
1990s
- Oct 15, 1990
Barr Laboratories — Marketing Organization
- Aug 23, 1991
Pharmacia & Upjohn — Marketing Organization
- Nov 27, 1991
Akorn, Inc. — NDA Secondary Org
- Nov 27, 1991
Epic Pharma Llc — NDA Secondary Org
- May 15, 1992
Mylan — Marketing Organization
- Aug 1, 1994
Hikma — Marketing Organization
- Feb 26, 1999
Fresenius — Marketing Organization
- Jun 17, 1999
Duramed Research — Marketing Organization
2000s
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 3 Sponsor(trial)
- Apr 30, 2007
Accord Research — Marketing Organization
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
- Mar 31, 2009
Sandoz — Marketing Organization
2010s
- Jan 8, 2010
Pharmachemie Bv — Marketing Organization
- Mar 29, 2012
Rising Pharmaceuticals — Marketing Organization
- Mar 29, 2012
EXTROVIS — Marketing Organization
- May 21, 2015
Sun Pharmaceuticals — Marketing Organization
- Jan 13, 2017
Zydus Discovery DMCC — Marketing Organization
- Apr 25, 2017
Silvergate Pharmaceuticals — Marketing Organization
- Apr 25, 2017
Azurity — Marketing Organization
- Dec 22, 2017
Amneal Pharmaceuticals — Marketing Organization
- Aug 9, 2018
Sagent Pharmaceuticals, Inc. — Marketing Organization
2020s
- Jan 30, 2020
Eugia Pharma — Marketing Organization
- Apr 23, 2021
Lotus Pharmaceutical — Marketing Organization
- Aug 7, 2023
Daito Pharmaceuticals — Marketing Organization
- May 16, 2024
Elite Laboratories, Inc — Marketing Organization
- Jun 3, 2024
Alembic — Marketing Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Autism Spectrum Disorder · Phase 4
- Biliary Tract Diseases · Phase 3
- Breast Neoplasms · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Cardiovascular Diseases · Phase 3
- Coronary Artery Disease · Phase 2
- COVID-19 · Phase 2
- Cystic Fibrosis · Phase 3
- Dermatology · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drugs, Investigational · Phase 1
- Drug Therapy · Phase 1
- End Stage Liver Disease · Phase 3
- Fallopian Tube Neoplasms · Phase 3
- General Surgery · Phase 2
- Glutathione · Phase 1
- Hamartoma · Phase 3
- HIV Infections · Phase 2
- Leukemia · Phase 2
- Liver Failure · Phase 3
- Myelodysplastic Syndromes · Phase 2
- Neurotoxicity Syndromes · Phase 3
- Ovarian Neoplasms · Phase 3
- Pain · Phase 3
- Pancreatic Neoplasms · Phase 2
- Parkinson Disease · Phase 2
- Peripheral Nerve Injuries · Phase 3
- Persian Gulf Syndrome · Phase 1/Phase 2
- Renal Insufficiency · Phase 2
- Reperfusion Injury · Phase 2
Mechanism of action
- Unspecified targetAntioxidant
antioxidant
Combination products
bss plus
with potassium chloride, sodium bicarbonate, sodium phosphate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as methotrexate sodium
Approval history
- approvedPriority reviewDec 7, 1953
Chemistry & pharmacology
SMILES
N[C@@H](CCC(=O)N[C@@H](CSSC[C@H](NC(=O)CC[C@H](N)C(=O)O)C(=O)NCC(=O)O)C(=O)NCC(=O)O)C(=O)O- Mol. weight
- 612.64 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaGlutathione ↗
- ChEMBLCHEMBL1543 ↗
- ChEMBLCHEMBL1372 ↗
- WikipediaGSH ↗
Also known as
- 5-l-glutamyl-l-cysteinylglycine
- 5-l-glutamyl-l-cysteinylglycine
- deltathione
- gamma-l-glutamyl-l-cysteinyl-glycine
- gamma-l-glutamyl-l-cysteinyl-glycine
- glutathion
- glutathione
- glutathione
- glutathione
- glutathione
- glutathione
- glutathione
- glutathione
- glutathione
- glutathione disulfide
- glutathione disulfide
- glutathione disulfide
- glutathione disulfide
- glutathione disulfide
- glutathione disulphide
- glutathione disulphide
- glutathione disulphide
- glutathione-sh
- glutathione-sh
- glutathione sodium
- gluthathione
- gluthathione
- glutinal
- gsh
- gsh
- gsh
- gssg
- gssg
- l-glutathione
- l-glutathione
- liposomal glutathione
- n-(n-gamma-l-glutamyl-l-cysteinyl)glycine
- n-(n-gamma-l-glutamyl-l-cysteinyl)glycine
- reduced glutathione
- reduced glutathione
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07304440 | N/A | Jan 15, 2026 | Adia Med of Winter Park LLC |
| NCT07302828 | N/A | Dec 15, 2025 | TCI Co., Ltd. |
| NCT07162623 | N/A | Aug 29, 2025 | NovoBliss Research Pvt Ltd, Zywie Ventures Pvt Ltd |
| NCT06922669 | N/A | Jun 24, 2025 | Government of China, Huazhong University of Science and Technology, People's Liberation Army of China, Shandong University, Tianjin Medical University |
| NCT06896422 | Phase 1 | Jun 1, 2025 | Zhengzhou University |
| NCT07202156 | N/A | Oct 20, 2024 | Nanjing Medical University |
| NCT06620523 | Phase 2 | Jul 18, 2024 | George Washington University |
| NCT05371288 | Early Phase 1 (Phase 1) | Jun 30, 2022 | University of California, Irvine |
| NCT05266417 | Phase 2 | Feb 7, 2022 | Gateway Institute for Brain Research |
| NCT04742725 | Phase 2 | May 25, 2021 | Innate Pharma, Regional Alliance for Sustainable Development |
| NCT04816487 | N/A | May 1, 2021 | Cairo University |
| NCT04672447 | N/A | Jul 1, 2020 | Kyowa Hakko Kogyo, Texas Tech University |
| NCT05954052 | Phase 4 | Jul 1, 2019 | University of Chicago |
| NCT03725241 | N/A | Oct 29, 2018 | Kyowa Hakko Kogyo, University of North Texas |
| NCT04105504 | Phase 1 | Apr 8, 2018 | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto |
| NCT03166371 | N/A | Jun 30, 2017 | Emory University, Your Energy Systems, L.L.C. |
| NCT03020719 | Phase 2 | Jun 14, 2017 | Cystic Fibrosis Foundation Therapeutics, Indiana University, University of Minnesota |
| NCT03306745 | N/A | Jun 2, 2017 | Medical University of Vienna |
| NCT02948673 | N/A | May 1, 2016 | University of Copenhagen |
| NCT02848417 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2016 | Department of Veteran Affairs, Nova University |
Organizations
Research & Development (71)
Marketing (41)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Abraxis | For profit | MKTG | Jun 13, 1986 |
| Accord Research | For profit | MKTG | Apr 30, 2007 |
| Akorn, Inc. | For profit | NDA2 | Nov 27, 1991 |
| Alcon | For profit | NDA2 | Oct 28, 1981 |
| Alembic | For profit | MKTG | Jun 3, 2024 |
| Amneal Pharmaceuticals | For profit | MKTG | Dec 22, 2017 |
| Azurity | For profit | MKTG | Apr 25, 2017 |
| Barr Laboratories | For profit | MKTG | Oct 15, 1990 |
| Bristol-Myers | For profit | MKTG | Sep 5, 1979 |
| Bristol-Myers Squibb | For profit | MKTG | Feb 14, 1985 |
| Bristol-Myers Squibb | For profit | SYN | Apr 14, 1989 |
| DAVA Pharmaceuticals | For profit | MKTG | Dec 7, 1953 |
| Daito Pharmaceuticals | For profit | MKTG | Aug 7, 2023 |
| Duramed Research | For profit | MKTG | Jun 17, 1999 |
| EXTROVIS | For profit | MKTG | Mar 29, 2012 |
| Elite Laboratories, Inc | For profit | MKTG | May 16, 2024 |
| Epic Pharma Llc | For profit | NDA2 | Nov 27, 1991 |
| Eugia Pharma | For profit | MKTG | Jan 30, 2020 |
| Eugia Pharma | For profit | SYN | Mar 29, 2012 |
| Fresenius | For profit | MKTG | Feb 26, 1999 |
| Hikma | For profit | MKTG | Aug 1, 1994 |
| Hikma | For profit | SYN | Sep 16, 1986 |
| Hospira | For profit | MKTG | Aug 10, 1959 |
| Lotus Pharmaceutical | For profit | MKTG | Apr 23, 2021 |
| Mylan | For profit | MKTG | May 15, 1992 |
| Mylan | For profit | SYN | Mar 29, 2012 |
| Nestle | For profit | NDA2 | Oct 28, 1981 |
| Nestle | For profit | NDA | Oct 28, 1981 |
| Norbrook | For profit | MKTG | May 9, 1986 |
| Pharmachemie Bv | For profit | MKTG | Jan 8, 2010 |
| Pharmachemie Bv | For profit | SYN | Jul 8, 1988 |
| Pharmacia & Upjohn | For profit | MKTG | Aug 23, 1991 |
| Rising Pharmaceuticals | For profit | MKTG | Mar 29, 2012 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Aug 9, 2018 |
| Sandoz | For profit | MKTG | Mar 31, 2009 |
| Sandoz | For profit | SYN | Mar 31, 2009 |
| Silvergate Pharmaceuticals | For profit | MKTG | Apr 25, 2017 |
| Strides Pharma Science | For profit | MKTG | Dec 7, 1953 |
| Sun Pharmaceuticals | For profit | MKTG | May 21, 2015 |
| West-Ward Pharmaceutical | For profit | MKTG | Sep 16, 1986 |
| Zydus Discovery DMCC | For profit | MKTG | Jan 13, 2017 |