potassium sulfate
Approved
Aug 5, 2010
Potassium sulfate (US) or potassium sulphate (UK), also called sulphate of potash (SOP), arcanite, or archaically potash of sulfur, is the inorganic compound with formula K2SO4, a white water-soluble solid. It is commonly used in fertilizers, providing both potassium and sulfur. — Wikipedia
Clinical trial activity
8 trials · 14 clinical orgs · 13 marketing orgs
Earliest trial started Jul 1, 2007 (NCT00503607)
Timeline
2000s
- Jan 1, 2007
Braintree Laboratories — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2007
Braintree Laboratories — Earliest Phase 3 Sponsor(trial)
2010s
- Aug 5, 2010
Braintree Laboratories — Earliest FDA Approval
- Aug 5, 2010
Braintree Laboratories — NDA Secondary Org
- Aug 5, 2010
Braintree Laboratories — NDA Organization
- Aug 18, 2016
Paddock Laboratories — Marketing Organization
- Aug 18, 2016
Perrigo — Marketing Organization
- Nov 14, 2016
Esteve Labs — Marketing Organization
- Dec 27, 2016
Gator Pharmaceuticals — NDA Secondary Org
- Feb 23, 2017
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Oct 26, 2018
Taro Pharmaceuticals — Marketing Organization
- Oct 26, 2018
Sun Pharmaceuticals — Marketing Organization
2020s
- Jun 15, 2021
Annora Pharma — Marketing Organization
- Nov 22, 2023
Strides Pharma Science — Marketing Organization
- Dec 29, 2023
Alkem Labs Ltd — Marketing Organization
- Jun 24, 2024
Bionpharma Inc — Marketing Organization
- Jul 15, 2024
Lannett Company, Inc. — Marketing Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Unknown
- Unspecified targetLaxative
laxative
Combination products
suclear
with potassium chloride, magnesium sulfate, sodium sulfate, sodium bicarbonate, sodium chloride, polyethylene glycol
suprep bowel prep
with magnesium sulfate, sodium sulfate
Also known as colprep
Approval history
- approvedAug 5, 2010
Chemistry & pharmacology
SMILES
O=S(=O)([O-])[O-].[K+].[K+]- Mol. weight
- 174.26 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- Yes
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaPotassium sulfate ↗
- ChEMBLCHEMBL2021424 ↗
Also known as
- k(2)so(4)
- magnesium sulfate mixture with potassium sulfate and sodium sulfate
- potassium sulfate
- potassium sulfate
- potassium sulfate
- potassium sulfate
- potassium sulfate (1:1)
- potassium sulfate, 35s-labeled
- pot sulf
- sulfuric acid, dipotassium salt
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05465889 | Phase 3 | May 15, 2019 | Changhai Hospital, Hebei Medical University, Henan Provincal People's Hospital, Jiao Tong University, Jilin University, Nanchang University, Peking University, Shandong University, Xiamen University |
| NCT03520361 | Phase 4 | Nov 2, 2017 | KangWon National University |
| NCT02523911 | N/A | Mar 1, 2016 | Iowa Digestive Disease Center, Mercy Medical Center, Des Moines, Iowa, University of Florida |
| NCT00756977 | Phase 3 | Aug 1, 2008 | Braintree Laboratories |
| NCT00756548 | Phase 3 | Aug 1, 2008 | Braintree Laboratories |
| NCT00583713 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2007 | Braintree Laboratories |
| NCT00503607 | Phase 3 | Jul 1, 2007 | Braintree Laboratories |
| NCT00503815 | Phase 3 | Jul 1, 2007 | Braintree Laboratories |
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Braintree Laboratories | For profit | 5 | 5 | 2 | 2007 |
| Changhai Hospital | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Hebei Medical University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Henan Provincal People's Hospital | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Iowa Digestive Disease Center | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Jiao Tong University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Jilin University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| KangWon National University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Mercy Medical Center, Des Moines, Iowa | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Nanchang University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Shandong University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Florida | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Xiamen University | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (15)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alkem Labs Ltd | For profit | MKTG | Dec 29, 2023 |
| Annora Pharma | For profit | MKTG | Jun 15, 2021 |
| Bionpharma Inc | For profit | MKTG | Jun 24, 2024 |
| Braintree Laboratories | For profit | NDA2 | Aug 5, 2010 |
| Braintree Laboratories | For profit | NDA | Aug 5, 2010 |
| Esteve Labs | For profit | MKTG | Nov 14, 2016 |
| Gator Pharmaceuticals | For profit | NDA2 | Dec 27, 2016 |
| Lannett Company, Inc. | For profit | MKTG | Jul 15, 2024 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Feb 23, 2017 |
| Paddock Laboratories | For profit | MKTG | Aug 18, 2016 |
| Perrigo | For profit | MKTG | Aug 18, 2016 |
| Strides Pharma Science | For profit | MKTG | Nov 22, 2023 |
| Sun Pharmaceuticals | For profit | MKTG | Oct 26, 2018 |
| Taro Pharmaceuticals | For profit | MKTG | Oct 26, 2018 |
| Taro Pharmaceuticals | For profit | SYN | Mar 19, 2024 |