tetrahydrobiopterin
Small moleculeexperimental
Tetrahydrobiopterin (BH4, THB), also known as sapropterin (INN), is a cofactor of the three aromatic amino acid hydroxylase enzymes, used in the metabolism of amino acid phenylalanine and in the biosynthesis of the neurotransmitters serotonin (5-hydroxytryptamine, 5-HT), melatonin, dopamine, norepinephrine (noradrenaline), epinephrine (adrenaline), and is a cofactor for the production of nitric oxide (NO) by the nitric oxide synthases. Chemically, its structure is that of a (dihydropteridine reductase) reduced pteridine derivative (quinonoid dihydrobiopterin). — Wikipedia
Clinical trial activity
11 trials · 9 clinical orgs · 0 marketing orgs
Phase 1
8
Phase 2
3
Phase 3
0
Phase 4
1
Earliest trial started Sep 1, 2008 (NCT02966665)
Timeline
Indications
Approved for
Studied for
- Cardiovascular Diseases · Phase 1
- Cystic Fibrosis · Phase 2
- Enteritis · Phase 2
- Heart Disease Risk Factors · Phase 1
- Heart Failure · Phase 1
- Heart Failure, Diastolic · Phase 1
- Heart Failure, Systolic · Early Phase 1
- Hypertension · Phase 1
- Hypertension, Pulmonary · Phase 1
- Inflammation · Phase 1
- Intermittent Claudication · Phase 1
- Oxidative Stress · Phase 1
- Peripheral Arterial Disease · Phase 1
- Peripheral Vascular Diseases · Phase 1
- Phenylketonurias · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 1
- Radiodermatitis · Phase 1
- Rheumatology · Phase 1/Phase 2
- Vasoconstriction · Phase 1
Mechanism of action
- Phenylalanine-4-hydroxylaseACTIVATOR
PAH activator
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTetrahydrobiopterin ↗
Also known as
- bh4
- bh4
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05138887 | Phase 2 | Dec 1, 2021 | Sichuan University |
| NCT05114226 | Phase 1 | Dec 1, 2021 | Sichuan University |
| NCT04800692 | Phase 1 | Jun 15, 2021 | National Institute on Aging (NIA), University of Massachusetts |
| NCT06312748 | Phase 1 | May 19, 2021 | Department of Veteran Affairs, University of Utah |
| NCT04227080 | Phase 4 | Jun 30, 2020 | Biomarin, Taipei Veteran General hospital |
| NCT04014712 | Phase 1 | Aug 31, 2019 | University of Massachusetts |
| NCT03136029 | Early Phase 1 (Phase 1) | Jun 1, 2018 | Department of Veteran Affairs, University of Utah |
| NCT03680573 | Phase 1 | Jan 8, 2018 | University of Texas, Arlington |
| NCT02530996 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2016 | Department of Veteran Affairs |
| NCT01772758 | Phase 2 | Aug 1, 2011 | Augusta University |
| NCT02966665 | Phase 1 | Sep 1, 2008 | Department of Veteran Affairs, University of Utah |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Department of Veteran Affairs | Government | 4 | 2 | 2 | 2008 |
| University of Utah | Academic/Hospital | 3 | 2 | 1 | 2008 |
| Sichuan University | Academic/Hospital | 2 | 2 | 2 | 2021 |
| University of Massachusetts | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Augusta University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Biomarin | For profit | 1 | 0 | 1 | 2020 |
| National Institute on Aging (NIA) | Government | 1 | 0 | 1 | 2021 |
| Taipei Veteran General hospital | Government | 1 | 1 | 1 | 2020 |
| University of Texas, Arlington | Academic/Hospital | 1 | 1 | 1 | 2018 |
9 organizations
Page 1 / 1