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Now FDA Approved

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Publications

Paltusotine

Phase 3 | ACROMEGALY

2025 | CONGRESS POSTER

Paltusotine in the Treatment of Surgically Naïve Patients With Acromegaly: Post Hoc Analysis of Three Clinical Trials

M. Martins, C. Boguszewski, R. Junik, et al.
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2024 | CONGRESS POSTER

Efficacy and Safety of Once-Daily Oral Paltusotine in Medically Untreated Patients with Acromegaly: Results from the Phase 3, Randomized, Placebo-Controlled PATHFNDR-2 Study

Beverly M.K. Biller, MD, Alessandra Casagrande, MD, PhD, Atanaska Elenkova, MD, et al.
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2023 | CONGRESS POSTER

Paltusotine Maintains IGF-I, GH, and Symptom Control in Patients With Acromegaly Switched From Injected Octreotide or Lanreotide Monotherapy: Topline Results From PATHFNDR-1, a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Monica R. Gadelha, MD, PhD, Alessandra Casagrande, MD, PhD, Christian J. Strasburger, MD; et al.
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Phase 3 | Carcinoid syndrome

2025 | CONGRESS POSTER

CAREFNDR: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

Aman Chauhan, MD, Martyn Caplin, MD, Rocio Garcia-Carbonero, MD, PhD, et al.
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2025 | CONGRESS POSTER

CAREFNDR: a Phase 3, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

Richard Kim, MD, et al.
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Phase 2 | ACROMEGALY

2024 | CONGRESS POSTER

Long-Term Safety and Efficacy of Once-Daily Oral Paltusotine in the Treatment of Patients With Acromegaly: Update From ACROBAT Advance

Monica R. Gadelha, MD, PhD, Harpal Randeva, MBChB, FRCP, FAcad TM, PhD, Murray B. Gordon, MD, et al.
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2023 | CONGRESS PRESENTATION

Oral Once-Daily, Paltusotine (Non-Peptide Selective Somatostatin Receptor Subtype 2 Agonist) Therapy in Patients With Acromegaly is Associated With Long-Term Biochemical and Symptom Control and is Preferred Over Injectable Somatostatin-Receptor Ligands

Monica R. Gadelha, MD, PhD, Harpal Randeva, MBChB, FRCP, FAcad TM, PhD, Murray B. Gordon, MD, et al.
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2022 | CONGRESS PRESENTATION

Paltusotine Shows Long-term Safety and IGF-1 Maintenance in the ACROBAT Advance Study

Monica R. Gadelha, MD, PhD, Murray B. Gordon, MD, Mirjana Doknic, MD, PhD, et al.
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2022 | CONGRESS POSTER

ACROBAT Advance: Long-term Safety and Efficacy Results of Paltusotine for the Treatment of Acromegaly

Harpal Randeva, PhD, Monica R. Gadelha, MD, PhD, Murray B. Gordon, MD, et al.
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2022 | CONGRESS PRESENTATION

ACROBAT Advance: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients with Acromegaly

Harpal Randeva, MBChB, FRCP, FAcad TM, PhD, Monica R. Gadelha, MD, PhD, Murray B. Gordon, MD, et al.
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2022 | JOURNAL ARTICLE

ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients with Acromegaly

Monica R. Gadelha, MD, PhD, Murray B. Gordon, MD, Mirjana Doknic, MD, PhD, et al.
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2021 | CONGRESS POSTER

ACROBAT Edge Phase 2 Study: Safety and Efficacy of Switching Injected Long-Acting Somatostatin Receptor Ligands (SRLs) to Once-Daily Oral Paltusotine

Monica R. Gadelha, MD, PhD, Murray B. Gordon, MD, Mirjana Doknic, MD, PhD, et al.
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Phase 2 | Carcinoid syndrome

2025 | CONGRESS POSTER

Investigator-Assessed Disease Progression in a Phase 2 Study of Paltusotine in Patients With Neuroendocrine Tumors and Carcinoid Syndrome

Amr Mohamed, MD, Michael J. Demeure, MD, MBA, Joseph Dillon, MD, et al.
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2025 | CONGRESS POSTER

Once-Daily Oral Paltusotine in the Treatment of Patients With Carcinoid Syndrome: Safety and Exploratory Efficacy Results From a Phase 2, Randomized, Parallel-Group Study

Lukasz Hajac, MD, PhD, et al.
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2023 | CONGRESS POSTER

A Phase 2, Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome

Aman Chauhan, MD, Shagufta Shaheen, MD, Keith Usiskin, MD, et al.
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Phase 1 | ACROMEGALY

2021 | CONGRESS POSTER

Pharmacokinetics and Safety of an Improved Formulation of Paltusotine, a Selective, Nonpeptide Somatostatin Receptor 2 (SST2) Agonist for the Treatment of Acromegaly

Rosa Luo, Gerald Burk, Cosina Mui, et al.
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2020 | CONGRESS POSTER

Absolute Oral Bioavailability and Absorption, Metabolism, Excretion of [14C]-Labeled Paltusotine (CRN00808), an Orally Bioavailable, Nonpeptide, Selective, Somatostatin Receptor 2 (SST2) Biased Agonist for the Treatment of Acromegaly

Ajay Madan, PhD, Rosa Luo, Christine Ferrara-Cook, MD, MhD, et al.
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2019 | CONGRESS POSTER

Final Results from the First in Man Phase 1 Clinical Trial of CRN00808, an Orally Bioavailable SST2-Selective, Nonpeptide Somatostatin Biased Agonist for the Treatment of Acromegaly: Safety, Pharmacokinetics, Pharmacodynamics, and Midazolam Drug Interaction in Healthy Volunteers

Ajay Madan, PhD, Yun Fei Zhu, PhD, Stacy Markison, et al.
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Phase 1 | General Research

2023 | CONGRESS POSTER

Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oral Paltusotine, a Non-Peptide, Selective Somatostatin Receptor Subtype 2 Agonist

Rosa Luo, MS, Alessandra Casagrande, MD, PhD, Sonic Oun, BA, et al.
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2022 | JOURNAL ARTICLE

Paltusotine, a Novel Oral Once Daily Nonpeptide SST2 Receptor Agonist, Suppresses GH and IGF1 in Healthy Volunteers

Ajay Madan, PhD, Stacy Markison, Stephen F. Betz, PhD, et al.
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RWE | ACROMEGALY

2025 | CONGRESS POSTER

Impact of Symptom Exacerbations in Patients With Medically Treated Acromegaly

E. B. Geer, D Clemmons, J. Sisco, M. Koobatian, J. Okeyo, T. Quock, Y. Wang, R. Colzani, A. Krasner
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HEOR | ACROMEGALY

2025 | ABSTRACT

Adherence, Duration, and Healthcare Costs in a Real-World Population of Patients With Acromegaly

Tiffany P. Quock, Eunice Chang, Ashis K. Das, et al.
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Discovery | General Research

2022 | JOURNAL ARTICLE

Discovery of Paltusotine (CRN00808), a Potent, Selective, and Orally Bioavailable Non-peptide SST2 Agonist

Jian Zhao, PhD, Shimiao Wang, Stacy Markison, et al.
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Atumelnant

Phase 2 | ACTH-Dependent Cushing Syndrome

2025 | ABSTRACT

Need to Pause Hydrocortisone? Physiologic Replacement Does Not Affect AM Serum Cortisol, Bedtime Salivary Cortisol or UFC in Cushing Syndrome Patients on Block and Replace Treatment

Henrik Elenius, MD, et al.
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2024 | CONGRESS POSTER

Atumelnant (CRN04894) Induces Rapid and Sustained Reductions in Serum and Urine Cortisol in Patients With ACTH-Dependent Cushing Syndrome During a Phase 1b/2a, Single Center, 10-Day, Inpatient, Open-Label Study

Henrik Elenius, Raven McGlotten, Casey Moore, et al.
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Phase 2 | Congenital adrenal hyperplasia

2024 | CONGRESS POSTER

Once Daily Oral Atumelnant (CRN04894) Induces Rapid and Profound Reductions of Androstenedione and 17-hydroxyprogesterone in Participants with Classical Congenital Adrenal Hyperplasia: Initial Results From a12-Week, Phase 2, Open-Label Study

Richard J. Auchus, MD, PhD, Peter J. Trainer, MD, Kathryn Jean Lucas, MD, et al.
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Phase 1 | General Research

2023 | CONGRESS POSTER

Waking Salivary 11-Hydroxyandrostenedione and Cortisone as a Novel Non-invasive Test for Adrenal Insufficiency

Alejandro Ayala, Carl LaCerte, Rosa Luo, et al.
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2022 | CONGRESS PRESENTATION

CRN04894 an oral, nonpeptide ACTH receptor antagonist reverses ACTH-stimulated glucocorticoid secretion in rodents and humans

Peter J. Trainer, Melissa Fowler, Alan Krasner, et al.
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2022 | CONGRESS PRESENTATION

Inhibition of Basal and ACTH-Stimulated Cortisol Secretion in Humans Using an Oral, Nonpeptide ACTH Antagonist (CRN04894)

Alan Krasner, Christine Ferrara-Cook, Rosa Luo, et al.
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2022 | CONGRESS PRESENTATION

CRN04894: Phase 1 Multiple Ascending Dose (MAD) Preliminary Results

Company Presentation
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2022 | CONGRESS PRESENTATION

CRN04894: First In Human Single Ascending Dose Preliminary Results

Company Presentation
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Discovery | General Research

2024 | JOURNAL ARTICLE

Discovery of CRN04894: A Novel Potent Selective MC2R Antagonist

Sun Hee Kim, et al.
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CRN09682

Phase 1 | General Research

2025 | CONGRESS POSTER

First-in-Human Study of a Novel, Nonradioactive, Nonpeptide Drug Conjugate(CRN09682) in Patients With Somatostatin Receptor 2-Expressing Tumors

Daneng Li, MD, Mohammed Najeeb Al Hallak, MD, MS. Lowell Anthony, MD, et. al
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Discovery | General Research

2024 | CONGRESS POSTER

Discovery of Nonpeptide Drug Conjugate (NDC) for the Treatment of Neuroendocrine Tumors (NETs) and Other SST2 Expressing Cancers

Jian Zhao, Emmanuel Sturchler, Bing Yang, et al.
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Oral PTH Antagonist

Pre-clinical | PHPT

2024 | CONGRESS POSTER

Blocking Activation of the Parathyroid Hormone Receptor Type 1 (PTH1R) with a Specific and Orally Available Antagonist is a Promising Therapy for the Treatment of Primary Hyperparathyroidism (PHPT)

Elizabeth Rico-Bautista, Joe Pontillo, Jonathan Shintaku, et al. Poster: Bone and Teeth Gordon Research Conference
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2023 | CONGRESS POSTER

Potent Parathyroid Hormone 1 Receptor Antagonists Suppress Receptor Activation and Downstream Pathways in Human Primary Osteoblasts

Jonathan Shintaku, Elizabeth Rico-Bautista, Joseph Pontillo, et al.
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2023 | CONGRESS POSTER

Effects of an Orally Bioavailable Nonpeptide Parathyroid Hormone Receptor Type 1 (PTH1R) Antagonist in Rodent Models of Primary Hyperparathyroidism (PHPT)

Agnes S. Antwan, Elizabeth Rico-Bautista, Joseph Pontillo
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2022 | CONGRESS POSTER

Discovery and Characterization of a Potent and Orally Bioavailable Parathyroid Hormone Receptor Type-1 (PTHR1) Antagonist for the Treatment of Hypercalcemia

Elizabeth Rico-Bautista, Joseph Pontillo, Shimiao Wang, et al.
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2021 | CONGRESS POSTER

Discovery of Potent and Orally Bioavailable Nonpeptide Parathyroid Hormone Receptor Type-1 (PTHR1) Antagonists for the Treatment of Primary Hyperparathyroidism (PHPT)

Elizabeth Rico-Bautista, Joseph Pontillo, Melissa A. Fowler, et al.
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