Paltusotine clinical trials
Also written CRN00808.
How each study uses Paltusotine 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
Approvals
The first approval found in each region, with its record
- United States
- 25 Sept 2025 · PALSONIFY · NDA 219070 (FDA, Drugs@FDA)
- European Union
- 23 Apr 2026 · Palsonify · EMEA/H/C/006636 (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
Studies by the year they started
9 studies that test it; most in 2019 (3)
| Year | Studies |
|---|---|
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2025 | 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 9 · Other 0
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 1, 1 in phase 3
Studies that test Paltusotine, phase 3 first.
- Aug 2027Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine RegimenPhase 3 · Crinetics Pharmaceuticals Inc.
Studies
Open first, then newest update. How each study uses Paltusotine 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 · 9
- Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine RegimenActive, not recruitingPhase 3Crinetics Pharmaceuticals Inc.NCT07087054Written as Paltusotine
- A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)TerminatedPhase 2Crinetics Pharmaceuticals Inc.NCT04261712Written as Paltusotine
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of AcromegalyTerminatedPhase 3Crinetics Pharmaceuticals Inc.NCT04837040Written as Paltusotine
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)TerminatedPhase 3Crinetics Pharmaceuticals Inc.NCT05192382Written as Paltusotine
- Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid SyndromeCompletedPhase 2Crinetics Pharmaceuticals Inc.NCT05361668Written as Randomized: 40 mg Paltusotine
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)CompletedPhase 2Crinetics Pharmaceuticals Inc.NCT03792555Written as Paltusotine
- An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)CompletedPhase 2Crinetics Pharmaceuticals Inc.NCT03789656Written as Paltusotine
- Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy VolunteersCompletedPhase 1Crinetics Pharmaceuticals Inc.NCT04246749Written as [14C]-CRN00808
- Single and Multiple-Ascending Dose Study of CRN00808 in Healthy VolunteersCompletedPhase 1Crinetics Pharmaceuticals Inc.NCT03276858Written as CRN00808
Codes
What other systems call Paltusotine · ClinicalTrials.gg INT002151
- MeSH (NLM) C000731874PaltusotineOne source NLM
- UNII (FDA) F2IBD1GMD3PALTUSOTINEConfirmed FDA, NLM, Wikidata
- Wikidata Q115869831paltusotineConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C175836PaltusotineOne source FDA
- DrugBank DB16277One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000731874 | Paltusotine | One source NLM |
| UNII (FDA) | F2IBD1GMD3 | PALTUSOTINE | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q115869831 | paltusotine | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C175836 | Paltusotine | One source FDA |
| DrugBank | DB16277 | — | One source Wikidata |
Also registered as paltusotine hydrochloride (UNII FZT5Z83JNS).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.