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Gut & neuroendocrine · Growth hormone axis

Lanreotide

A long-acting somatostatin analogue with pivotal-trial evidence for slowing tumour progression in certain neuroendocrine tumours.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

Also known as: Somatuline Depot, lanreotide acetate

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
84/100
Human safety
82/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved with pivotal trial evidence in GEP-NETs

Overview

Human evidence84/100
Preclinical evidence80/100
Human safety evidence82/100

Clinical maturity: Approved with pivotal trial evidence in GEP-NETs

Routes & formulations

Studied / approved routes

SC injection

The approved product is a deep subcutaneous depot injection administered by a healthcare professional on a fixed schedule.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic somatostatin analogue in a long-acting depot formulation.

What people claim

  • Controls acromegaly
  • Extends progression-free survival in certain gastroenteropancreatic neuroendocrine tumours

What the evidence actually says

Beyond symptom control, a large randomised trial demonstrated improved progression-free survival in GEP-NETs — outcome-level evidence, not a surrogate.

Human evidence

  • Randomised controlled trial evidence for progression-free survival in GEP-NETs.
  • Controlled trials and clinical experience in acromegaly.

Preclinical evidence

  • Somatostatin receptor pharmacology and antiproliferative models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • SSTR2-dominant agonism suppresses hormone secretion and exerts antiproliferative effects in SSTR-expressing tumours.

Safety and unknowns

  • Labelled effects include gallbladder abnormalities, gastrointestinal effects and injection-site reactions.

Cancer relevance

No concern identified

An anticancer therapy in its own right for certain neuroendocrine tumours — the opposite of a cancer-risk concern.

Regulatory status

FDA-approved (Somatuline Depot) for acromegaly and for the treatment of adults with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Indication-specific approvals.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Not applicable at this evidence tier.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.