FDA Approved Growth Hormone Axis

Lanreotide

also known as: Somatuline Depot, Somatuline Autogel

The second-generation somatostatin analog (FDA-approved as Somatuline Depot, 2007 for acromegaly; 2014 for GEP-NETs; 2017 for carcinoid) — monthly deep-SC prefilled syringe. Functionally equivalent to octreotide LAR for most indications.

A synthetic long-acting cyclic octapeptide somatostatin analog, FDA-approved as Somatuline Depot for acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome; marketed by Ipsen as a monthly deep-subcutaneous prefilled-syringe formulation that is largely interchangeable with octreotide LAR in acromegaly management.

Mechanism of action

Preferentially binds SSTR2 and SSTR5, inhibiting growth hormone, insulin-like growth factor 1, serotonin, and other neuroendocrine hormone release. The CLARINET trial established an antiproliferative benefit in GEP-NETs independent of hormone symptom control — extending use of somatostatin analogs from symptom management to tumor-stabilizing therapy.

Primary uses

Acromegaly
Gastroenteropancreatic neuroendocrine tumors (tumor control, CLARINET indication)
Carcinoid syndrome (flushing and diarrhea)

Typical dosing

60–120 mg every 4 weeks (deep subcutaneous (pre-filled syringe))

Starting dose typically 90 mg monthly; titrated based on GH/IGF-1 or tumor response.

Regulatory status

FDA-approved as Somatuline Depot (2007) for acromegaly, with expansions to gastroenteropancreatic neuroendocrine tumors (2014, on the CLARINET trial) and carcinoid syndrome (2017). Manufactured by Ipsen.

References

[fda-pi] Somatuline Depot (lanreotide) Prescribing Information. Ipsen Biopharmaceuticals.
[pubmed] Caplin ME, et al. "Lanreotide in metastatic enteropancreatic neuroendocrine tumors (CLARINET)." N Engl J Med, 2014;371:224-233.

Related peptides

Octreotide

The first-generation somatostatin analog (FDA-approved as Sandostatin, 1988) — the pharmacological counterweight to growth-hormone excess. Used for acromegaly, carcinoid syndrome, and VIPoma; now available in injectable, LAR-depot, and oral (Mycapssa, 2020) formulations.

Somatropin (HGH)

FDA-approved recombinant human growth hormone — the direct hormone replacement, with multiple clinical indications, prescription-only status, and specific federal criminal provisions against off-label distribution.

Tesamorelin

An FDA-approved GHRH analog for reducing excess visceral fat in HIV-associated lipodystrophy.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.