Pasireotide (Signifor)_Dosage, benefits & legal status
Also known as Signifor, Signifor LAR, SOM230, pasireotide diaspartate, pasireotide pamoate
A ring-shaped six-residue drug for Cushing's disease and acromegaly, traded for a high rate of diabetes.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Pasireotide (Signifor)?
Plain language first. The technical label stays, but it never stands alone.Overview
Pituitary tumours that cause Cushing's disease carry lots of receptor 5, so pasireotide can switch down the hormone signal that drives cortisol. In its main Cushing's trial, cortisol returned to normal in 15 to 26% at 6 months. The cost is blood sugar: hyperglycaemia-related side effects affected 73% of people in that trial.
Pasireotide is a head-to-tail cyclic hexapeptide that binds somatostatin receptors 1, 2, 3 and 5, with its strongest grip on subtype 5, where octreotide binds 35 to 200 times more weakly. Novartis developed it as SOM230; Recordati Rare Diseases has owned it since 2019. It comes as a twice-daily injection under the skin (Signifor) and a monthly injection into muscle (Signifor LAR).
What it's used for
A prescription injection for Cushing's disease when pituitary surgery has failed or is not possible, and (as the monthly LAR) for acromegaly not controlled by surgery.
How does Pasireotide (Signifor) work?
What it does in the body, and where.Pasireotide is a somatostatin copy built to reach more of the five receptor subtypes than octreotide does.
- 01Wider reachLabel binding figures: 0.16 nanomolar at subtype 5, 1.0 at subtype 2, 1.5 at subtype 3 and 9.3 at subtype 1. Octreotide binds subtype 5 at 5.6 to 32 nanomolar.
- 02Cortisol and growth hormone downThe ACTH-secreting tumours of Cushing's disease are rich in subtype 5, so pasireotide cuts ACTH and then cortisol. In acromegaly, subtypes 2 and 5 on the tumour lower growth hormone and IGF-1.
- 03
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Cushing's disease
FDA-approved- Human trialTwice-daily injection, 162 adults: cortisol normal at month 6 in 15% and 26%; median fall about 47% at both doses.
- Human trialMonthly LAR, 150 adults: cortisol normal at month 7 in about 40% on either dose.
- Human trialPatients starting with cortisol up to 5 times normal responded more often.
Acromegaly
FDA-approved- Human trialHead to head in untreated acromegaly: controlled in 31.3% against 19.2% on octreotide LAR 20 mg.
- No dataDiabetes prevalence rose from 30% at the start to 60% at month 12 in that trial (US label).
Failed or not reproduced
tested-and-failed- Human trialCarcinoid syndrome: symptom control 20.9% against 26.7% on octreotide; stopped for futility.
- Human observationPancreatic leaks: 9% against 21% at one centre, but 7.1% against 7.1% in a later matched study at another.
The '73%' figure is hyperglycaemia-related adverse events in the NEJM Cushing's paper; the label's own terms give hyperglycaemia 40% and diabetes 18%. The '50% cortisol reduction' is the median fall, not normalisation (15 to 26%), and the trial had no placebo. The LAR was approved for Cushing's disease in 2018, not 2020, and the EU approved Signifor before the US. 'Selective for receptor 5' is loose: it binds subtype 2 at about 1 nanomolar too. The 10 mg LAR Cushing's response is 39.2% in the US label and 41.9% in the paper. The pancreatic leak benefit came from a single centre and was not reproduced. It has no disulfide bridge, unlike octreotide and lanreotide.
The published record
Papers and trials about Pasireotide (Signifor)
413 papers tagged human · 224 not reviews or lab · 69 clinical trial publications
87 registered trials · 40 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 467 papers and 87 trials indexed in detail.
At a glance
Four things to know about Pasireotide (Signifor)
Evidence
FDA-approved
Category
Sexual and hormonal
Common vial
Varies
Half-life
About 12 hours (twice-daily injection)
How much, and do you cycle it?
The range, and whether you take breaks.0.3 to 0.9 mg twice daily, or 10 to 60 mg monthly LAR (label), twice daily (signifor) or every 28 days (signifor lar). Continuous, set by the prescription FDA label
Taken long term while it controls cortisol or growth hormone and is tolerated.
About 12 hours (twice-daily injection)FDA label
Effective half-life in healthy volunteers after injection under the skin; peak at 15 to 30 minutes. Mostly cleared unchanged through the liver and bile. The LAR label gives no half-life: levels burst on day 1, dip, then peak around day 21, reaching steady state after three injections.
Source: Signifor prescribing information section 12.3
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Pasireotide (Signifor) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 50% charged residues, 67% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Poorly controlled diabetes: check glucose and HbA1c first, since blood sugar rises in most people
- Severe liver impairment (Child-Pugh C): the label says to avoid it
- Slow heart rate, heart block, a long QT interval, or other drugs that prolong QT
- Gallbladder disease, since gallstones appeared in up to a third of trial patients
- Pregnancy: data are insufficient, and rabbit studies showed delayed development below human exposure
Stop and get help
- Extreme thirst, passing a lot of urine, confusion or fruity-smelling breath: possible very high blood sugar or ketoacidosis
- Weakness, dizziness, nausea and low blood pressure: possible cortisol falling too low
- Severe pain under the right ribs, fever or yellowing skin
- Fainting or a very slow pulse
Common effects
- Diarrhoea in 58% and nausea in 52% (twice-daily injection, Cushing's trial)
- Hyperglycaemia in 40% and diabetes in 18% as labelled terms; HbA1c rose from 5.8% to about 7.2% by month 6
- Gallstones in 30%
- Headache in 28%, injection-site reactions in 17% and hair loss in 12%
- In acromegaly, hyperglycaemia-related events in 57.3% against 21.7% on octreotide
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Pasireotide (Signifor) approved?
And where the numbers on this page come from.Yes. Pasireotide (Signifor) is FDA approved and available on prescription in the United States. It is also approved in the European Union and Japan.
- Approval statusFDA-approved
- RouteUnder the skin twice daily, or a monthly injection into muscle (LAR)
- Checked13 October 2026
- Approved outside the USEuropean Union, Japan: EU authorisation 24 April 2012 for Cushing's disease, with the monthly form for acromegaly from November 2014 (narrower than the US indication). Japan approved the LAR for acromegaly in 2016 and Cushing's disease in 2018. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesSignifor prescribing information (7/2024)Signifor LAR prescribing information (7/2024)Drugs@FDA, NDA 203255 (Signifor LAR)EMA, Signifor EPARFDA GSRS substance record, pasireotide (UNII 98H1T17066)Biller BMK et al., BMC Endocrine Disorders 2010;10:10, table 2Colao A et al., New England Journal of Medicine 2012;366:914-924 (B2305)Colao A et al., Journal of Clinical Endocrinology & Metabolism 2014;99:791-799 (C2305)Gadelha MR et al., Lancet Diabetes & Endocrinology 2014;2:875-884 (PAOLA)Lacroix A et al., Lancet Diabetes & Endocrinology 2018;6:17-26 (G2304)Wolin EM et al., Drug Design, Development and Therapy 2015;9:5075-5086Allen PJ et al., New England Journal of Medicine 2014;370:2014-2022Dominguez-Rosado I et al., Journal of the American College of Surgeons 2018;226:147-154
What has happened recently
The EU authorised it first, on 24 April 2012, for Cushing's disease. The FDA approved the twice-daily injection on 14 December 2012 (NDA 200677) for adults with Cushing's disease for whom pituitary surgery is not an option or has not been curative, the monthly LAR for acromegaly on 15 December 2014 (NDA 203255) and the LAR for Cushing's disease on 29 June 2018. A ketoacidosis warning and, in 2024, a fat malabsorption warning were added. Recordati bought worldwide rights from Novartis in 2019 for $390 million upfront. Japan approved the LAR for acromegaly in 2016 and Cushing's disease in 2018. No generic is approved; the twice-daily product's only listed US patent expires on 14 December 2026. The EU acromegaly indication is narrower, requiring failure of another somatostatin analogue.
You can compare this against the whole library, or read how to check a seller.
What else is like Pasireotide (Signifor)?
Others in Sexual and hormonal, side by side.If you're weighing Pasireotide (Signifor), it's worth reading PT-142, RYZ101 (actinium-225 dotatate), and Terlipressin (Terlivaz) in the same class.
A ring-shaped six-residue drug for Cushing's disease and acromegaly, traded for a high rate of diabetes.
- Dose
- 0.3 to 0.9 mg twice daily, or 10 to 60 mg monthly LAR (label)
- How often
- Twice daily (Signifor) or every 28 days (Signifor LAR)
A Palatin-style code number with no published compound behind it.
- Dose
- Research only
- How often
- Not established
The same tumour-seeking peptide as Lutathera with a far more destructive alpha-emitting payload, still in trials.
- Dose
- 10.2 MBq every 8 weeks, 4 doses (phase 3)
- How often
- Every 8 weeks, for 4 doses
A hospital-only vasopressin analog for hepatorenal syndrome, with a boxed warning for fatal respiratory failure.
- Dose
- 0.85 to 1.7 mg every 6 hours (label)
- How often
- Every 6 hours for up to 14 days
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Signifor prescribing information (7/2024)(2024)0.3 to 0.9 mg twice daily; effective half-life about 12 hours; receptor binding table; adverse reactions in 162 Cushing's patients: diarrhoea 58%, hyperglycaemia 40%, gallstones 30%.
- Signifor LAR prescribing information (7/2024)(2024)Monthly doses for acromegaly and Cushing's disease; ketoacidosis warning; no half-life stated for the LAR.
- Drugs@FDA, NDA 203255 (Signifor LAR)(2026)Acromegaly approved 15 December 2014; Cushing's disease added 29 June 2018.
- EMA, Signifor EPAR(2026)EU authorisation 24 April 2012, eight months before the FDA; acromegaly limited to people inadequately controlled on another analogue.
- FDA GSRS substance record, pasireotide (UNII 98H1T17066)(2026)C58H66N10O9, MW 1047.21, CAS 396091-73-9; structure of the head-to-tail ring.
- Biller BMK et al., BMC Endocrine Disorders 2010;10:10, table 2(2010)Published receptor binding ranges for octreotide, including subtype 5 at 5.6 to 32 nanomolar.
- Colao A et al., New England Journal of Medicine 2012;366:914-924 (B2305)(2012)162 adults with Cushing's disease, no placebo: urine cortisol normal at month 6 in 15% (0.6 mg) and 26% (0.9 mg); hyperglycaemia-related events in 73%.
- Colao A et al., Journal of Clinical Endocrinology & Metabolism 2014;99:791-799 (C2305)(2014)358 people with untreated acromegaly: control at 12 months 31.3% on pasireotide LAR against 19.2% on octreotide LAR.
- Gadelha MR et al., Lancet Diabetes & Endocrinology 2014;2:875-884 (PAOLA)(2014)198 people uncontrolled on octreotide or lanreotide: control 15.4% (40 mg) and 20.0% (60 mg) against 0%.
- Lacroix A et al., Lancet Diabetes & Endocrinology 2018;6:17-26 (G2304)(2018)150 people with Cushing's disease on the LAR: cortisol normal at month 7 in 41.9% (10 mg) and 40.8% (30 mg); the US label gives 39.2% for 10 mg.
- Wolin EM et al., Drug Design, Development and Therapy 2015;9:5075-5086(2015)Carcinoid syndrome phase 3, 110 randomised: symptom control 20.9% against 26.7% on octreotide; stopped for futility.
- Allen PJ et al., New England Journal of Medicine 2014;370:2014-2022(2014)Single centre, 300 pancreatic resections: severe leak, fistula or abscess 9% against 21% on placebo.
- Dominguez-Rosado I et al., Journal of the American College of Surgeons 2018;226:147-154(2018)112 matched pairs at another centre: severe fistula 7.1% with and without pasireotide.
Beyond these, 554 records are indexed. Browse the records