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    DRUG:

    Palsonify (paltusotine)

    i
    Other names: CRN00808, CRN-00808
    Associations

    News

    Trials
    Company:
    Crinetics, Suzuken
    Drug class:
    SSTR2 agonist
    Associations

    News

    Trials
    7d
    A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (clinicaltrials.gov)
    P3, N=111, Completed, Crinetics Pharmaceuticals Inc. | Active, not recruiting --> Completed | Completed --> Active, not recruiting
    Trial completion • Enrollment closed
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    IGF1 (Insulin-like growth factor 1)
    |
    Palsonify (paltusotine)
    17d
    PATHFNDR 1: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (clinicaltrials.gov)
    P3, N=58, Completed, Crinetics Pharmaceuticals Inc. | Active, not recruiting --> Completed
    Trial completion
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    SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
    |
    Palsonify (paltusotine)
    20d
    CRN00808-11: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome (clinicaltrials.gov)
    P2, N=36, Completed, Crinetics Pharmaceuticals Inc. | Active, not recruiting --> Completed
    Trial completion
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    Palsonify (paltusotine)
    1m
    CRN00808-11: Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome (2024-511922-30-00)
    P1/2, N=2, Completed, Crinetics Pharmaceuticals Inc. | Active, not recruiting --> Completed
    Trial completion
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    SSTR (Somatostatin Receptor)
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    SSTR positive
    |
    Palsonify (paltusotine)
    5ms
    A Phase 1, Single-Dose, Open-Label, Randomized, Three-Period, Two-Sequence, Crossover Study to Evaluate the Relative Bioavailability of Paltusotine Low Drug Load (LDL) Tablets 60 mg (2 × 30 mg LDL tablet) and High Drug Load (HDL) Tablet 60 mg (1 × 60 mg HDL tablet) in Healthy Volunteers. (ACTRN12625001148460)
    P1, N=20, Not yet recruiting, Crinetics Pharmaceuticals, Inc
    New P1 trial
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    Palsonify (paltusotine)
    6ms
    Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-Daily Oral Paltusotine Treatment. (PubMed, J Clin Endocrinol Metab)
    IGF-I normalized in significantly more patients with uncontrolled acromegaly treated with paltusotine versus placebo. Paltusotine was associated with rapid, sustained IGF-I reduction, significant symptom improvement, and stable or reduced pituitary tumor size and was well tolerated.
    Clinical • Journal
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    SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1) • SSTR2 (Somatostatin Receptor 2)
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    Palsonify (paltusotine)
    6ms
    Paltusotine versus octreotide: different effects on radioligand uptake in neuroendocrine tumours. (PubMed, Endocr Oncol)
    Treatment with paltusotine did not significantly reduce radioligand binding of 18F-SiTATE in vitro, indicating no influence on SSTR2 targeting. This might enable a continuation of somatostatin receptor analogue therapy with paltusotine during PRRT, potentially improving symptom control in GEP-NET patients with the carcinoid syndrome.
    Journal
    |
    SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
    |
    Palsonify (paltusotine)
    9ms
    CAREFNDR: Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen (clinicaltrials.gov)
    P3, N=141, Recruiting, Crinetics Pharmaceuticals Inc.
    New P3 trial
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    Palsonify (paltusotine)
    1year
    "Cold" Somatostatin Analogs in Neuroendocrine Neoplasms: Decoding Mechanisms, Overcoming Resistance, and Shaping the Future of Therapy. (PubMed, Cells)
    This paper provides a comprehensive analysis of the cellular and molecular mechanisms of SSAs. SSAs remain integral to the management of NENs, providing effective tumor stabilization and symptom control. However, resistance mechanisms and tumor heterogeneity necessitate innovative approaches, including high-dose regimens, combination strategies, and next-generation formulations. Future research should focus on refining these strategies to optimize patient outcomes, enhance long-term efficacy, and expand the therapeutic landscape for NENs.
    Review • Journal
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    SSTR (Somatostatin Receptor)
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    Oclaiz (octreotide subcutaneous depot) • Palsonify (paltusotine)
    almost2years
    Oral Octreotide Capsules and Paltusotine in Management of Acromegaly. (PubMed, touchREV Endocrinol)
    Adverse events with both OOC and paltusotine were reflective of those recognized with iSRL and occurred at a similar frequency. OOC and paltusotine are well-received additions to the therapeutic armamentarium in medical therapy for the management of acromegaly; however, further data on efficacy, tumour control and shrinkage are required to allow positioning of this medication within the management algorithm for acromegaly.
    Review • Journal
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    SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
    |
    Palsonify (paltusotine)
    2years
    A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (clinicaltrials.gov)
    P3, N=111, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Trial completion date: Jan 2026 --> Jan 2028
    Trial completion date
    |
    IGF1 (Insulin-like growth factor 1)
    |
    Palsonify (paltusotine)
    2years
    PATHFNDR 1: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (clinicaltrials.gov)
    P3, N=58, Active, not recruiting, Crinetics Pharmaceuticals Inc. | Trial completion date: Jun 2025 --> Jun 2027
    Trial completion date
    |
    SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
    |
    Palsonify (paltusotine)