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sapropterin

Generic: SAPROPTERIN DIHYDROCHLORIDE·Brand: Javygtor, KUVAN, Kuvan, SAPROPTERIN DIHYDROCHLORIDE, ZELVYSIA, Zelvysia

sapropterin: sourced relationships with 1 company · 2 clinical trials tracked · 3 FDA decisions.

sapropterin evidence translation

What we can confirm

3 FDA records · 2 tracked trials

What it means

Source-backed records connect sapropterin to RDY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could sapropterin → RDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
DR REDDYS LABORATORIES LTD (RDY)
Reported 2021-03-30 · Current development: unknownSource
Approved
Clinical Trial Registry Records (2)

Rhode Island Diastolic Dysfunction - Heart Failure

NCT02353312Registry updated 2025-07-03·N/A
Completed

Primary endpoint: Change From Baseline in Oxygen Consumption During Maximal Bike Exercise

InterventionalRandomizedopen28 enrolledStarted 2015-03Completion 2018-121 site · United StatesProvidence VA Medical Center

Pilot Study to Assess Impact of Kuvan® Supplementation as an Adjunct Treatment in Subjects With Dominantly-inherited GTPCH Deficiency on Mood, Behavioral and Motor Phenotypes

NCT01425528Registry updated 2025-04-01·Phase 1/Phase 2
Completed

Primary endpoint: Change in BH4 Levels in Cerebral Spinal Fluid

Interventionalopen12 enrolledStarted 2011-08Completion 2013-081 site · United StatesUniversity of Utah
FDA Decisions3 records
Approval(RDY)FDA ↗
ANDA215798UNKNOWNStandardOralFor Solution
Approval(RDY)FDA ↗
ANDA207685UNKNOWNStandardOralTablet
Approval(RDY)FDA ↗
ANDA209452UNKNOWNStandardOralFor Solution

Frequently asked questions

Which companies have sourced relationships with sapropterin?

sapropterin has dated SEC/FDA relationship records for DR REDDYS LABORATORIES LTD.

How many clinical trials involve sapropterin?

BioSniper tracks 2 clinical trials involving sapropterin.

What is sapropterin's latest FDA decision?

The most recent tracked FDA decision for sapropterin is Approval, dated May 13, 2022.