Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tetrahydrobiopterin/kg · 1 trial · 3 indications
Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD).
| Arm | Type | Description |
|---|---|---|
| Tetrahydrobiopterin Dose 1 (Day 0 to 44) | EXPERIMENTAL | All subjects will receive 3300mg l-Ascorbate , l-Arginine 3400mg and 10mg/kg of Tetrahydrobiopterin once a day. |
| Tetrahydrobiopterin Dose 2 (Day 45 to 90) | EXPERIMENTAL | All subjects will receive 3300mg l-Ascorbate, l-Arginine 3400mg and 20mg/kg of Tetrahydrobiopterin once a day. |
| Name | Type | Description |
|---|---|---|
| Tetrahydrobiopterin 10 mg/kg | DRUG | 10mg/kg of Tetrahydrobiopterin daily. |
| Tetrahydrobiopterin 20 mg/kg | DRUG | 20mg/kg of Tetrahydrobiopterin daily. |
| L-Ascorbate | DRUG | 3300 mg of l-ascorbate once daily |
| L-Arginine | DRUG | 3400mg of l-arginine once daily |
Inclusion Criteria: * PAD as demonstrated by an ABI \<0 .9 in one leg or TBI less than \<0.7 in patients with an ABI \>1.3 (non compressible vessels) * Rutherford Classification II, III * Age \>18 years old * Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Le...
Tetrahydrobiopterin/kg is an investigational small molecule being studied for the treatment of intermittent claudication, a condition characterized by leg pain due to inadequate blood flow. It is being evaluated in patients with peripheral artery disease and peripheral vascular diseases. The drug is currently in Phase 1 clinical development.
Tetrahydrobiopterin/kg is being studied for its effects on nitric oxide bioavailability in patients with intermittent claudication. The ongoing clinical trial aims to assess how the drug influences nitric oxide levels, which are important for blood vessel function and blood flow. The exact mechanism of action is being investigated in this Phase 1 study.
Tetrahydrobiopterin/kg is being developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug's effects in patients with intermittent claudication. BioMarin is listed on the stock market under the ticker symbol BMRN.
Tetrahydrobiopterin/kg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 10 patients.
Tetrahydrobiopterin/kg is being studied in a Phase 1 clinical trial with the identifier NCT04800692. The trial is titled 'The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication' and is being conducted in the United States. The study is active but not recruiting, with an enrollment of 10 participants.
Yes, Tetrahydrobiopterin/kg is also known as Tetrahydrobiopterin 10 mg/kg. Both names refer to the same investigational drug being developed by BioMarin Pharmaceutical Inc. for the treatment of intermittent claudication. The drug is currently in Phase 1 clinical trials.