Clinical Trial of Paltusotine, an oral somatostatin analogue for the Treatment of Carcinoid Syndrome

Update 20th November 2025 
Crinetics Announces First Patient Randomized in Pivotal Phase 3 CAREFNDR Trial Evaluating Paltusotine in Carcinoid Syndrome

Read the news – click here

Clinical Trial Document – click here

Limited to US (22 locations), Spain, France, Argentina, Brazil (so far).

Update 25th September 2025 – Crinetics

Crinetics Announces FDA Approval of PALSONIFY™ (paltusotine) for the Treatment of Acromegaly in Adults

– September 25, 2025

Read more – click here.

Learn more about PALSONIFY BY clicking here.

Note:  Approval of somatostatin analogues for acromegaly normally precedes approval for NET. 

UPDATE 14th March 2024

Results from Paltusotine Carcinoid

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

Headline:
EFFICACY FINDINGS: Rapid and Sustained Reductions in Patient Symptoms
SAFETY: Once Daily Oral Paltusotine Showed Positive Results in
Carcinoid Syndrome Patients

Efficacy and safety findings support progressing to a pivotal phase 3 trial (pending discussions with the FDA). Paltusotine is an investigational drug in clinical studies for the treatment of acromegaly and carcinoid syndrome. Flushing: 63% reduction in frequency for patients with >1/day (p< 0.0001). Flushing Severity: 61% reduction in severity of episodes (p<0.0001) Excess Bowel Movement: 60% reduction in frequency for patients with >3/day (p=0.02) Bowel Movement Urgency: 64% reduction in urgent episodes (p<0.0001).

Click here to read more.

Phase 2 Clinical Trials Document – click here.

Original post

Crinetics Pharmaceuticals, Inc. a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumours.  They have a lead molecule, paltusotine (also referred to as CRN01941 for NET and more recently as CRN00808 for Acromegaly and NET),

Phase 3 trial for Acromegaly is complete awaiting publication of results.

The company is also developing oral nonpeptide somatostatin agonists for hyperinsulinism, as well as oral nonpeptide ACTH antagonists for the treatment of Cushing’s disease and an SST5 antagonist for hyperinsulinism.

What is Paltusotine

Paltusotine is the first oral, once-daily, selectively targeted somatostatin receptor type 2 (SST2) agonist being developed for the treatment of acromegaly and carcinoid syndrome. The method of operation appears to be similar in that it wants to bind to somatostatin receptor 2 (SST2).

* chemical that binds to a receptor and activates the receptor to produce a biological response.

In the meantime, see short video and note that the drug for Acromegaly is more advanced in pipeline terms (now in Phase 3).

Paltusotine for Neuroendocrine Tumors (NETs)

In terms of the effect on NETs, these tumours typically over express SST2, somatostatin type 2 receptors. Both SST2 and 3 are involved in apoptosis of neuroendocrine tumour cells.” Paltusotine’s high level of selectivity for the SST2 receptor may translate into better efficacy in the treatment of neuroendocrine tumours given the role of the SST2 receptor. In fact, Crinetics describes paltusotine as an “oral selective SST2 agonist” differentiating it from existing molecules lacking this selectivity.

For more information, please visit http://www.crinetics.com

The Phase 1 Clinical Trial of Paltusotine (formerly CRN01941) for NETs

The trial is initially only based in Perth Western Australia with a target of around 120 participants. It is not yet known if there are any plans to expand locations in subsequent phases or parts of the trial.  It also appears they are trialling the use of a capsule-based drug and another delivery method as yet unknown; the clinical trial only mentions “Oral Solution”, so it isn’t an injection. Read more at ClinicalTrials.gov using the identifier NCT03936166.  This trial is now complete.

This is not the first somatostatin receptor-based product in the pipeline, please also check out my article about Somatostatin Analogues and Delivery Mechanisms in the pipeline – click here.

Summary of sources:

1. Press Release – click here.
2. Manufacturers Website – click here.
3. Phase 1 Clinical Trials Document – click here.
4. Phase 2 Clinical Trials Document – click here.

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional. Some content may be generated by AI which can sometimes be misinterpreted.  Please check any references attached.

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.

Finally

Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document.   Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

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