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Paltusotine

Generic Name
Paltusotine
Drug Type
Small Molecule
Chemical Formula
C27H22F2N4O
CAS Number
2172870-89-0
Unique Ingredient Identifier
F2IBD1GMD3
Background

Paltusotine is under investigation in clinical trial NCT04261712 (A Study to Evaluate the Long-term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)).

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

Phase 2
Active, not recruiting
Conditions
Carcinoid Syndrome
Carcinoid Tumor of Ileum
Carcinoid Intestine Tumor
Carcinoid Tumor of Liver
Carcinoid Tumor
Carcinoid Tumor of Cecum
Carcinoid Syndrome Diarrhea
Carcinoid Tumor of Pancreas
Carcinoid
First Posted Date
2022-05-05
Last Posted Date
2024-02-01
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
36
Registration Number
NCT05361668
Locations
🇵🇪

Crinetics Study Site Peru #2, Lima, Peru

🇵🇱

Crinetics Study Site, Wrocław, Poland

🇵🇪

Crinetics Study Site Peru #1, Lima, Peru

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Phase 3
Active, not recruiting
Conditions
Acromegaly
Interventions
Drug: Placebo
First Posted Date
2022-01-14
Last Posted Date
2025-03-28
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
111
Registration Number
NCT05192382
Locations
🇬🇧

Crinetics Study Site, London, United Kingdom

🇬🇷

Crinetics Study Site (a), Athens, Greece

🇬🇷

Crinetics Study Site (b), Athens, Greece

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Phase 3
Active, not recruiting
Conditions
Acromegaly
Interventions
Drug: Placebo
First Posted Date
2021-04-08
Last Posted Date
2024-07-10
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
58
Registration Number
NCT04837040
Locations
🇬🇧

Crinetics Study Site, London, United Kingdom

A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

Phase 2
Active, not recruiting
Conditions
Acromegaly
Interventions
First Posted Date
2020-02-10
Last Posted Date
2024-12-18
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
43
Registration Number
NCT04261712
Locations
🇬🇷

Crinetics Study Site 1, Athens, Greece

🇬🇷

Crinetics Study Site 2, Athens, Greece

🇬🇧

Crinetics Study Site, Leeds, United Kingdom

Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: [14C]-CRN00808
First Posted Date
2020-01-29
Last Posted Date
2020-01-29
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
11
Registration Number
NCT04246749
Locations
🇳🇱

PRA Health Sciences, Groningen, Netherlands

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Phase 2
Completed
Conditions
Acromegaly
Interventions
Drug: Placebo
First Posted Date
2019-01-03
Last Posted Date
2025-03-17
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
13
Registration Number
NCT03792555
Locations
🇬🇷

General Hospital of Athens "Gennimatas", Athens, Greece

🇭🇺

Semmelweis University Faculty of Medicine, Budapest, Hungary

🇭🇺

University of Pécs Medical School, Pécs, Hungary

and more 8 locations

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Phase 2
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2018-12-28
Last Posted Date
2025-02-17
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
47
Registration Number
NCT03789656
Locations
🇺🇸

UCLA Gonda Diabetes Center, Los Angeles, California, United States

🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 23 locations

Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo Oral Solution
Drug: Placebo oral capsule
First Posted Date
2017-09-08
Last Posted Date
2018-08-29
Lead Sponsor
Crinetics Pharmaceuticals Inc.
Target Recruit Count
99
Registration Number
NCT03276858
Locations
🇦🇺

Nucleus Network, Melbourne, Victoria, Australia

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