Pegtibatinase clinical trials
Also written TVT-058 and OT-58.
How each study uses pegtibatinase 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
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Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
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
3 studies that test it; most in 2019 (1)
| Year | Studies |
|---|---|
| 2019 | 1 |
| 2023 | 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 3 · Other 0
Travere Therapeutics, Inc. (3)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 2, 1 in phase 3
Studies that test pegtibatinase, phase 3 first.
- Aug 2027Pegtibatinase as a Treatment for Participants With Classical Homocystinuria (HCU) Receiving Standard of Care TreatmentPhase 3 · Travere Therapeutics, Inc.
- Jul 2027Pegtibatinase as a Treatment for Patients With Classical Homocystinuria (HCU) (Also Known as the COMPOSE Study)Phase 1/2 · Travere Therapeutics, Inc.
Studies
Open first, then newest update. How each study uses pegtibatinase 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 · 3
- A Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE) (ENSEMBLE)Enrolling by invitationPhase 3Travere Therapeutics, Inc.NCT06431893Written as Pegtibatinase
- Pegtibatinase as a Treatment for Participants With Classical Homocystinuria (HCU) Receiving Standard of Care TreatmentRecruitingPhase 3Travere Therapeutics, Inc.NCT06247085Written as Pegtibatinase
- Pegtibatinase as a Treatment for Patients With Classical Homocystinuria (HCU) (Also Known as the COMPOSE Study)RecruitingPhase 1/2Travere Therapeutics, Inc.NCT03406611Written as Pegtibatinase
Codes
What other systems call pegtibatinase · ClinicalTrials.gg INT014662
- UNII (FDA) 3G3529LUQ7PEGTIBATINASEOne source FDA
- NCI Thesaurus C175837PegtibatinaseOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| UNII (FDA) | 3G3529LUQ7 | PEGTIBATINASE | One source FDA |
| NCI Thesaurus | C175837 | Pegtibatinase | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.