Sepiapterin clinical trials
Also written PTC923 and Sephience.
How each study uses sepiapterin is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
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Approvals
The first approval found in each region, with its record
- United States
- 28 Jul 2025 · SEPHIENCE · NDA 219666 (FDA, Drugs@FDA)
- European Union
- 19 Jun 2025 · Sephience · EMEA/H/C/006331 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
5 studies that test it; most in 2019 (2)
| Year | Studies |
|---|---|
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 5 · Other 0
Studies
Open first, then newest update. How each study uses sepiapterin is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 5
- A Study of Sepiapterin in Participants With Phenylketonuria (PKU)RecruitingPhase 3PTC TherapeuticsNCT06302348Written as Sepiapterin
- A Long-Term Safety Study of PTC923 in Participants With PhenylketonuriaCompletedPhase 3PTC TherapeuticsNCT05166161Written as PTC923
- A Study of PTC923 in Participants With PhenylketonuriaCompletedPhase 3PTC TherapeuticsNCT05099640Written as PTC923
- A Study of PTC923 (CNSA-001) in Primary Tetrahydrobiopterin (BH4) Deficient Participants With HyperphenylalaninemiaCompletedPhase 1/2PTC TherapeuticsNCT03519711Written as PTC923
- A Study of CNSA-001 in Women With Diabetic GastroparesisCompletedPhase 2PTC TherapeuticsNCT03712124Written as CNSA-001
Codes
What other systems call sepiapterin · ClinicalTrials.gg INT002659
- MeSH (NLM) C016727sepiapterinConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) CJQ26KO7HPSEPIAPTERINConfirmed FDA, NLM, Wikidata
- Wikidata Q100606475L-sepiapterinConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C188559SepiapterinOne source FDA
- DrugBank DB16326One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C016727 | sepiapterin | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | CJQ26KO7HP | SEPIAPTERIN | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q100606475 | L-sepiapterin | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C188559 | Sepiapterin | One source FDA |
| DrugBank | DB16326 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.