Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library · Trial & Regulatory Tracker →
Pasireotide (Signifor / Signifor LAR): what the evidence says
At a glance
What it is: a somatostatin analogue that binds SSTR5 strongly, plus SSTR1, 2 and 3. R1 FDA approved Signifor (NDA 200677) and Signifor LAR (NDA 203255). R2, R3
What the evidence says: in Cushing's disease, 12 of 82 and 21 of 80 patients reached normal urine cortisol at month 6. R1 In untreated acromegaly, it controlled disease in 31% vs 19% with octreotide LAR. R4 It also helped patients not controlled on older drugs (PAOLA). R5
Biggest risks: high blood sugar: 118 of 162 Cushing's patients had hyperglycemia events. R1
Rating
| Human Human evidence | Strong: phase 3 RCTs, n = 162 to 358 R1, R4, R5 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R2, R3 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R6, R7, R8 · not named by WADA R9 |
| Established human dose | Yes, label dose |
Evidence verdict: Cushing's disease: Strong (FDA-approved; works in a minority) · Acromegaly: Strong (FDA-approved) · Blood sugar harm: Serious concern (most patients)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: phase 3 trials with clear endpoints. The Cushing's response rate is modest, and high blood sugar is common.
What is it?
Related pages: Octreotide, Lanreotide, Pegvisomant.
Does it work?
- Human Cushing's disease: about half the patients saw urine cortisol fall by roughly 50% by month 2. R1
- Human Acromegaly, first drug: control 31.3% vs 19.2% with octreotide LAR at 12 months. R4
- Human Acromegaly, not controlled on older drugs (PAOLA): better control than continuing octreotide or lanreotide. R5
Is it safe?
- Human 74 of 162 Cushing's patients needed a new glucose-lowering drug. R1 Hyperglycemia events were 57.3% vs 21.7% with octreotide in acromegaly. R4
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved prescription drug. R2, R3
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R6, R7, R8
- Sport: not named on WADA's 2026 Prohibited List. R9
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Cushing's phase 3 2012 | 162 adults | SC twice daily | 600 or 900 µg | 12 months | Normal UFC in 12/82 and 21/80 | PMID 22397653 |
| Acromegaly C2305 2014 | 358 adults | IM monthly (LAR) | 40 mg (up to 60 mg) | 12 months | Control 31.3% vs 19.2% | PMID 24423324 |
| PAOLA 2014 | Adults not controlled | IM monthly (LAR) | 40 or 60 mg | 24 weeks | Better control vs active control | PMID 25260838 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Colao A, et al. N Engl J Med. 2012. PMID 22397653
- R2 Drugs@FDA, Signifor (pasireotide diaspartate), application NDA 200677 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 200677
- R3 Drugs@FDA, Signifor LAR (pasireotide pamoate), application NDA 203255 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 203255
- R4 Colao A, et al. J Clin Endocrinol Metab. 2014. PMID 24423324
- R5 Gadelha MR, et al. Lancet Diabetes Endocrinol. 2014. PMID 25260838
- R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Pasireotide (Signifor / Signifor LAR). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).