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Gastrointestinal · FDA Approved

Pasireotide (Signifor)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A multireceptor-targeted somatostatin analog with affinity for SSTR1, SSTR2, SSTR3 and SSTR5, including high affinity for SSTR5 (PMID 22397653) (PMID 23733372). Corticotroph adenomas in Cushing disease express predominantly SSTR5, and in laboratory studies pasireotide inhibited ACTH release from cultured human corticotroph adenoma cells more consistently than octreotide (PMID 15817922).

This receptor profile is the basis for its use to lower ACTH and cortisol in Cushing disease.

02 · Research summary & key findings

FDA-approved for Cushing disease (Signifor, 2012) and, as a long-acting release formulation, for acromegaly (2014). In a 12-month phase 3 trial in Cushing disease, urinary free cortisol normalized at month 6 in 15% to 26% of patients depending on dose (Colao et al., NEJM, 2012) (PMID 22397653). In the PAOLA trial of acromegaly not controlled on octreotide or lanreotide, 15% to 20% of patients achieved biochemical control on pasireotide vs. none who continued their prior drug (PMID 25260838). Hyperglycemia is the main side effect, caused by reduced insulin secretion and incretin responses rather than reduced insulin sensitivity (PMID 23733372) (PMID 22397653).

03 · Regulatory status

Pasireotide (Signifor) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Pasireotide (Signifor) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Subcutaneous injection (twice daily)
  • Intramuscular injection (monthly LAR)

References

  1. [1]The multi-ligand somatostatin analogue SOM230 inhibits ACTH secretion by cultured human corticotroph adenomas via somatostatin receptor type 5 Eur J Endocrinol, 2005. PMID 15817922
  2. [2]A 12-month phase 3 study of pasireotide in Cushing's disease N Engl J Med, 2012. PMID 22397653
  3. [3]Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers J Clin Endocrinol Metab, 2013. PMID 23733372
  4. [4]Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial Lancet Diabetes Endocrinol, 2014. PMID 25260838

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.