Summary

Lanreotide is a synthetic cyclic octapeptide analogue of somatostatin, developed by Ipsen and marketed as Somatuline Autogel. With a half-life of approximately 23 days in depot form, it is far more stable than endogenous somatostatin (2–3 minutes). Lanreotide is a licensed medicine approved by the MHRA, EMA, and FDA for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Supported by multiple Phase 3 RCTs — including the CLARINET trial published in NEJM (2014) and the PRIMARYS study — lanreotide has strong clinical evidence for its licensed indications. Emerging research also investigates its use in autosomal dominant polycystic kidney disease (ADPKD) and polycystic liver disease.

Overview

Lanreotide is a synthetic cyclic octapeptide analogue of somatostatin, developed in the 1990s by Ipsen. It mimics the natural hormone somatostatin but with significantly improved metabolic stability — a half-life of approximately 23 days as a depot formulation, compared to somatostatin's 2–3 minutes. Lanreotide is marketed under the brand name Somatuline (Somatuline Autogel in the UK/EU; Somatuline Depot in the US).

The peptide is a licensed medicine approved by the MHRA, EMA, and FDA for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs). It is one of the most widely prescribed somatostatin analogues in clinical practice, alongside octreotide.

In the research peptide community, lanreotide is occasionally discussed as a reference compound for somatostatin receptor pharmacology and as a comparator in studies of novel SST analogues. It is not a substance typically encountered in non-medical research settings due to its prescription-only status and specialised clinical indications.

Research Summary

Acromegaly — Strong Clinical Evidence

Lanreotide is a first-line medical therapy for acromegaly, supported by decades of clinical data.

The PRIMARYS study (Caron et al., Lancet Diabetes & Endocrinology, 2014) was a pivotal prospective, open-label trial in 90 treatment-naïve acromegalic patients. At 52 weeks, 63% of patients achieved controlled GH levels (<2.5 µg/L) and 41% achieved normalised IGF-1. The study established lanreotide depot as an effective first-line medical therapy.

The SODA study (Salvatori et al., 2014) further demonstrated that lanreotide depot maintained biochemical control in 59% of patients over 4 years of treatment.

Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)

The CLARINET trial (Caplin et al., NEJM, 2014) was a landmark Phase 3 randomised, double-blind, placebo-controlled study in 204 patients with well-differentiated metastatic GEP-NETs. Lanreotide significantly prolonged progression-free survival (PFS) — median PFS was not reached in the lanreotide group versus 18 months for placebo (hazard ratio 0.47, 95% CI 0.30–0.73; p<0.001). This led to the FDA and EMA approvals for GEP-NET treatment.

Emerging Research: Polycystic Kidney Disease and Liver Disease

Lanreotide has been investigated in autosomal dominant polycystic kidney disease (ADPKD). The ALADIN trial (Caroli et al., 2013) showed a modest reduction in total kidney volume growth over 6 months. A follow-up study (ALADIN 2) suggested sustained benefit over 120 weeks, though results were mixed.

In polycystic liver disease (PLD) associated with ADPKD, lanreotide has shown more consistent benefit in reducing liver volume. The DIPAK-1 trial (Neijenhuis et al., Lancet, 2017) demonstrated a 3.0% reduction in liver volume with lanreotide versus 1.6% growth with standard care.

Evidence grade: Strong — supported by multiple Phase 3 RCTs and long-term observational data for acromegaly and GEP-NETs. Evidence in ADPKD/PLD is moderate and emerging.

Commonly Discussed Protocols

All protocols below are documented from clinical trial literature and prescribing information for research reference only. Lanreotide is a licensed POM in the UK and must only be administered under medical supervision.

Acromegaly

  • Starting dose: Lanreotide Autogel 60 mg, 90 mg, or 120 mg deep subcutaneous injection
  • Titration: Dose adjusted every 4 weeks based on GH and IGF-1 response (60 → 90 → 120 mg)
  • Route: Deep subcutaneous injection (upper outer quadrant of buttock)
  • Frequency: Every 4 weeks

GEP-NETs

  • Dose: Lanreotide Autogel 120 mg deep subcutaneous injection
  • Frequency: Every 4 weeks
  • Source: CLARINET trial protocol and licensed indication

ADPKD / Polycystic Liver Disease (Investigational)

  • Dose: Lanreotide Autogel 90–120 mg
  • Frequency: Every 4 weeks
  • Duration: Trials ranged from 6 months to 2.5 years
  • Note: Not a licensed indication — investigational use only

Stacking

There is no established research literature on combining lanreotide with other peptides in the research community. In clinical practice, combination with pegvisomant (a GH receptor antagonist) is used in refractory acromegaly. Lanreotide should not be co-administered with other somatostatin analogues (e.g., octreotide, pasireotide) as this provides no therapeutic advantage and may increase side effects.

Storage & Reconstitution

Lanreotide Autogel is supplied as a pre-filled syringe containing a sustained-release gel formulation. This is NOT a lyophilised peptide requiring reconstitution.

  • Storage: Store at 2–8°C (refrigerated). Do not freeze. Keep in original packaging to protect from light.
  • Pre-administration: Remove from refrigerator 30 minutes prior to injection to allow it to reach room temperature. Do not warm artificially.
  • Shelf life: Typically 24 months from manufacture when stored correctly.
  • Note for research compound form: If acquired as a lyophilised research chemical (non-pharmaceutical grade), store at -20°C and reconstitute with bacteriostatic water. Note that such preparations lack the sustained-release depot formulation and will have a dramatically shorter half-life.

Blood Work

In clinical practice, the following biomarkers are monitored during lanreotide therapy:

  • Growth Hormone (GH): Target <2.5 µg/L (acromegaly). Measured every 4–12 weeks during titration, then every 6 months.
  • Insulin-like Growth Factor 1 (IGF-1): Target within age-adjusted normal range. Monitored alongside GH.
  • Fasting blood glucose / HbA1c: Lanreotide can alter glucose homeostasis — both hyperglycaemia and hypoglycaemia have been reported. Regular monitoring is essential.
  • Thyroid function: Monitor TSH, as somatostatin analogues can suppress TSH.
  • Vitamin B12: Long-term use may reduce B12 absorption; periodic monitoring recommended.
  • Gallbladder ultrasound: Annual screening for gallstones (common adverse effect of somatostatin analogues).
  • Liver function tests: Monitored in GEP-NET patients with hepatic metastases.

UK Legal Status

Lanreotide is a Prescription-Only Medicine (POM) in the UK, licensed by the MHRA for:

  • Acromegaly (when surgery and/or radiotherapy have failed or are not appropriate)
  • Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) — Grade 1 and some Grade 2
  • Symptoms of carcinoid syndrome

It is supplied as Somatuline Autogel (Ipsen) via NHS prescription. Unlicensed supply for human use is illegal. Purchase of non-pharmaceutical-grade lanreotide by research institutions for in vitro or animal studies is legal under research chemical exemptions, but suppliers must not market it for human consumption.

References

References

  1. Caron P, Bex M, Cullen DR, et al. PRIMARYS: Lanreotide Autogel primary therapy in acromegaly. Lancet Diabetes Endocrinol. 2014;2(11):881-9. doi:10.1016/S2213-8587(14)70121-X
  2. Caplin ME, Pavel M, Cwikła JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors (CLARINET). N Engl J Med. 2014;371(3):224-33. doi:10.1056/NEJMoa1316558
  3. Salvatori R, Gadelha MR, Mejia JC, et al. SODA study: lanreotide Autogel in acromegaly. Pituitary. 2014;17(5):436-43. doi:10.1007/s11102-013-0530-y
  4. Caroli A, Perico N, Perna A, et al. ALADIN: effect of lanreotide on kidney volume in ADPKD. J Am Soc Nephrol. 2013;24(10):1655-66. doi:10.1681/ASN.2012120112
  5. Neijenhuis MK, Gevers TJ, Hogan MC, et al. DIPAK-1: lanreotide in polycystic liver and kidney disease. Lancet. 2017;390(10103):1664. doi:10.1016/S0140-6736(17)32045-9
  6. Somatuline Autogel (lanreotide) Summary of Product Characteristics. Ipsen Ltd. MHRA. Accessed 2025.