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Endocrine (other)

Pasireotide

Also called Signifor, Signifor LAR, SOM230, pasireotide diaspartate, pasireotide pamoate

Pasireotide is a man-made, ring-shaped peptide that copies the natural hormone somatostatin. It is an FDA-approved prescription drug for adults with Cushing's disease (too much cortisol caused by a pituitary tumor) and for adults with acromegaly (too much growth hormone) when surgery has not worked or is not an option. Its best-known downside is high blood sugar, which is very common and can lead to diabetes.

FDA-approvedApproved by the FDA for at least one use after large human trials.

New · under editorial review. Added October 30, 2026 by our automated research, with every claim sourced. A person has not checked this page yet; treat it with extra care. How we research

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Illustrative chain. The exact sequence has not been published in a source we could verify.

Overview

Pasireotide is a man-made, ring-shaped peptide that copies the natural hormone somatostatin. It is an FDA-approved prescription drug for adults with Cushing's disease (too much cortisol caused by a pituitary tumor) and for adults with acromegaly (too much growth hormone) when surgery has not worked or is not an option. Its best-known downside is high blood sugar, which is very common and can lead to diabetes.

How it works

Established: pasireotide binds to somatostatin receptors and switches them on. It binds most tightly to receptor subtype 5 (more tightly than natural somatostatin does), less tightly to subtypes 2, 3 and 1, and hardly at all to subtype 4 1. The pituitary tumors that cause Cushing's disease often carry many subtype-5 receptors, so activating them lowers ACTH release and, in turn, cortisol 1. In acromegaly it lowers growth hormone and IGF-1 2. High blood sugar happens because, in a study of healthy volunteers, pasireotide lowered insulin release and the gut hormones GLP-1 and GIP 1.

What research shows

  • Cushing's disease, twice-daily injection (phase 3 RCT, n=162): urine cortisol became normal at month 6 without a dose increase in 15% on 0.6 mg and 26% on 0.9 mg twice daily; median urine cortisol fell by about half by month 2. Hyperglycemia-related side effects occurred in 118 of 162 people, and 74 started glucose-lowering drugs 6.
  • Cushing's disease, monthly LAR (phase 3 RCT, n=150): urine cortisol was normal at month 7 in 41.9% on 10 mg and 40.8% on 30 mg every 4 weeks in the published paper 9; the FDA label's analysis reports 39.2% and 40.8% 2.
  • Acromegaly, untreated patients (double-blind RCT, n=358, 12 months): 31.3% on pasireotide LAR reached growth hormone below 2.5 mcg/L with normal IGF-1, vs 19.2% on octreotide LAR (P=0.007). Hyperglycemia-related events were 57.3% vs 21.7% 7.
  • Acromegaly not controlled on octreotide or lanreotide (PAOLA, phase 3 RCT, n=198, 24 weeks): 15% on 40 mg and 20% on 60 mg LAR reached control vs 0% of those kept on their old drug. Diabetes was reported in 21% and 26% vs 8% 8.
  • In the LAR trials, the share of people with diabetes rose from 30% to 60% (untreated acromegaly, month 12), from 71% to 87% and 60% to 84% (previously treated acromegaly, 40 and 60 mg, month 6) and from 40% to 56% (Cushing's disease, month 12) 2.

Doses studied in people

Study or labelDose usedSource
FDA label, Signifor (Cushing's disease)Starting dose 0.6 mg or 0.9 mg twice a day by subcutaneous injection; label range 0.3–0.9 mg twice a day1
FDA label, Signifor LAR (acromegaly)Starting dose 40 mg intramuscular once every 4 weeks; may be raised to a maximum of 60 mg2
FDA label, Signifor LAR (Cushing's disease)Starting dose 10 mg intramuscular once every 4 weeks; may be raised up to a maximum of 40 mg2
Phase 3 RCT in Cushing's disease (n=162)0.6 mg or 0.9 mg subcutaneous twice daily6
Phase 3 RCT in Cushing's disease, LAR (n=150)10 mg or 30 mg intramuscular every 4 weeks9
Phase 3 RCT in acromegaly (n=358)Pasireotide LAR 40 mg every 28 days, optional increase to 60 mg7

Doses shown come only from the FDA labels and published phase 3 trials; they are reported, not recommended. Lower maximum doses apply in moderate liver impairment 12.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Safety

  • High blood sugar and diabetes are the main risk. In the Cushing's trial, hyperglycemia was reported in 40% and diabetes in 18%; average HbA1c rose from 5.8% to 7.2–7.3% by month 6, and it stayed above baseline a month after stopping 1.
  • LAR label: some people were hospitalized for very high blood sugar, and one developed diabetic ketoacidosis; ketoacidosis has also been reported after marketing, including in people without prior diabetes 2.
  • Most common side effects with the twice-daily form (phase 3, n=162): diarrhea 58%, nausea 52%, hyperglycemia 40%, gallstones 30%, headache 28%, belly pain 24% 1.
  • Label warnings: low cortisol (hypocortisolism), slow heart rate and QT prolongation, raised liver tests, gallstones and their complications, loss of other pituitary hormones, and fatty stools from poor fat absorption (added July 2024) 12.
  • Safety and effectiveness in people under 18 have not been established 1.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

History

Pasireotide was developed by Novartis. The European Commission approved Signifor for Cushing's disease in April 2012 1011, and the FDA approved the twice-daily injection for Cushing's disease on December 14, 2012 3; Novartis described it as the first U.S. medicine aimed at the underlying cause of the disease 10. The once-monthly Signifor LAR was approved for acromegaly on December 15, 2014 4, and FDA added Cushing's disease to the LAR label in a June 29, 2018 supplement 45. In July 2019 Recordati agreed to acquire global rights to Signifor and Signifor LAR from Novartis 14; Recordati Rare Diseases is now the U.S. sponsor 34.

Common questions

Is pasireotide FDA-approved?

Yes. Signifor (twice-daily injection) was approved for Cushing's disease in 2012, and the monthly Signifor LAR was approved for acromegaly in 2014 and for Cushing's disease in 2018 345.

How well does it work for Cushing's disease?

In the main trial of the twice-daily form, urine cortisol became normal by month 6 in 15% to 26% of people, depending on dose 6. With the monthly form, about 40% had normal urine cortisol at month 7 9.

Why does pasireotide raise blood sugar?

It lowers insulin release and the gut hormones GLP-1 and GIP 1. In trials, high blood sugar was one of the most common side effects, and many people needed diabetes medicine 16.

How is it different from octreotide?

Pasireotide binds most strongly to somatostatin receptor 5 as well as 1, 2 and 3 1. In untreated acromegaly it controlled hormone levels in more people than octreotide LAR (31.3% vs 19.2%), but caused more high blood sugar 7.

What are the other main risks?

The labels warn about low cortisol, slow heart rate and QT changes, liver test rises, gallstones, loss of other pituitary hormones, and fatty stools 12.

Is pasireotide banned in sport?

It is not named on the WADA 2026 Prohibited List 13.

Related compounds

Endocrine (other)FDA-approvedFlashcard

Octreotide

Sandostatin · Sandostatin LAR Depot

Octreotide is a long-acting, man-made version of somatostatin, the body's 'off switch' for many hormones.

Growth hormone axisFDA-approvedFlashcard

Somatropin (human growth hormone)

hGH · HGH

Somatropin is a lab-made copy of human growth hormone, the pituitary hormone that drives growth in children and helps control body fat and muscle in adults.

Growth hormone axisFDA-approvedFlashcard

Mecasermin

Increlex · rhIGF-1

Mecasermin is a lab-made copy of human IGF-1, the hormone that growth hormone normally tells the liver to make.

Growth hormone axisFDA-approvedFlashcard

Macimorelin

Macrilen · AEZS-130

Macimorelin is an oral ghrelin-like drug used as a one-time test for growth hormone deficiency in adults.

Sources

  1. Signifor (pasireotide) injection Prescribing Information, revised 7/2024 (FDA) FDA label
  2. Signifor LAR (pasireotide) for injectable suspension Prescribing Information, revised 7/2024 (FDA) FDA label
  3. Drugs@FDA: NDA 200677 Signifor (original approval 12/14/2012) Regulatory
  4. Drugs@FDA: NDA 203255 Signifor LAR (original approval 12/15/2014; new-indication supplement 06/29/2018) Regulatory
  5. FDA supplement approval letter, NDA 203255/S-004: Signifor LAR new indication for Cushing's disease (2018) Regulatory
  6. Colao A et al. A 12-month phase 3 study of pasireotide in Cushing's disease. N Engl J Med 2012;366(10):914-24 (PMID 22397653) Journal
  7. Colao A et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab 2014;99(3):791-9 (PMID 24423324) Journal
  8. Gadelha MR et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA). Lancet Diabetes Endocrinol 2014;2(11):875-84 (PMID 25260838) Journal
  9. Lacroix A et al. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol 2018;6(1):17-26 (PMID 29032078) Journal
  10. Novartis press release: Signifor gains FDA approval as first medication to treat Cushing's disease (Dec 2012) Regulatory
  11. EMA: Signifor (pasireotide) EPAR overview Regulatory
  12. PubChem: Pasireotide (CID 9941444) – formula, molecular weight, CAS 396091-73-9, synonym SOM230 Database
  13. WADA 2026 Prohibited List, full text (official WADA file as hosted by Asia Rugby) Regulatory
  14. Pharmaceutical Technology: Recordati to acquire Signifor and osilodrostat rights from Novartis (July 15, 2019) Regulatory

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Last reviewed 2026-10-30 · How we research · Found an error? See our corrections policy.