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Drugs in development · updated 30 October 2026

Tetrahydrobiopterin: clinical trials and development status

Other names and codes: Sapropterin Dihydrochloride, 6R-BH4, Kuvan, Sapropterin Dipharma

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 2 December 2008

As of 30 October 2026 Tetrahydrobiopterin is in 3 active clinical trials (recruiting or ongoing, phases I–III) for 7 diseases. The most advanced phase is II.

3Active trials
IIMost advanced phase
7Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Tetrahydrobiopterin and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Arterial hypertensionII1NCT02947750
Chronic renal insufficiencyII1NCT02947750
Kidney diseaseII1NCT02947750
Intermittent claudicationI1NCT04800692
Peripheral Arterial DiseaseI1NCT04800692
Peripheral vascular diseaseI1NCT04800692
PhenylketonuriaI1NCT07255599

Everything on Tetrahydrobiopterin

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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