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تصوير الهيكل المثالي لـ Lanreotide
P 065Lanreotide

المطابق المثالي المبني من التسلسل؛ ليست بنية تجريبية أو متوقعة.

تصوير الهيكل المثالي لـ البنية الكيميائية لـ Lanreotide (ثنائية الأبعاد)
P 065 · 2Dالبنية الكيميائية (ثنائية الأبعاد)

تصوير ثنائي الأبعاد من PubChem SMILES

P 065تم التحقق 2026-08-06
الدواء المعتمد

Lanreotide

الأسماء المستعارة: Somatuline · Somatuline Autogel · Somatuline Depot · BIM-23014

FDA- and EMA-approved somatostatin analog for acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.

الجهاز الهضمي والغدد الصماء والقلب والأوعية الدموية

يتم الاحتفاظ بمحتوى الأدلة باللغة الإنجليزية.

تصوير الهيكل المثالي لـ Lanreotide

المطابق المثالي المبني من التسلسل؛ ليست بنية تجريبية أو متوقعة.

لمحة سريعة

ENTRY TYPE
approved drug
IDENTITY
Sequence verified

No structure asset recorded

TOP EVIDENCE
Grade A — Acromegaly
MAJOR STATUS
Jurisdiction-specific — see status table
SPORT
Prohibited — as of 2026-08-06
VERIFIED
2026-08-06

Bottom line

Lanreotide is a synthetic octapeptide somatostatin analog with SSTR2 and SSTR5 affinity comparable to octreotide but formulated as a ready-to-use deep depot (Autogel) that requires no . Approved for acromegaly, gastroenteropancreatic neuroendocrine tumors (), and carcinoid syndrome. The CLARINET study demonstrated tumor growth control in non-functioning enteropancreatic NETs.

Identity and composition

FieldVerified information
Preferred nameLanreotide
Key aliasesSomatuline Autogel (deep ), Somatuline Depot (deep SC in US; in some non-US markets), BIM-23014
Molecular/sequence identityD-Nal-Cys-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2 (octapeptide amide); disulfide bridge Cys2–Cys7; D-Nal = D-3-(2-naphthyl)alanyl
Modifications/formAcetate salt; deep SC depot injection (Autogel, prefilled syringe) and IM microparticle formulation (Depot)
Stable identifiersUNII: 0G3DE8943Y; : 6918011; CAS: 108736-35-2 (base); DrugBank: DB09079
Identity caveatsDistinct octapeptide from octreotide — uses D-Nal and Val substitutions. Sequence does not match native somatostatin.

Development and approval status

JurisdictionStatus and indicationProduct/sourceAs of
US (FDA)Approved: acromegaly, (unresectable, well- or moderately differentiated, locally advanced or metastatic), carcinoid syndromeSomatuline Depot (Ipsen) — deep injectionAug 2007; NET indication Dec 2014; carcinoid syndrome indication
EU/EEA (EMA)Approved: acromegaly, GEP-NETs, TSH-secreting pituitary tumorsSomatuline Autogel2001
UK (MHRA)Approved: same indicationsSomatuline Autogel2001
Status is multi-axis
Lanreotide authorization and sport-status profileFour medicine-authorization axes reproduce only documented status rows; sport status is shown separately.UNITED STATESApproved: acromegaly, GEP-NETs(unresectable, well- orSOURCE / AS OFROW 1 / Aug 2007; NET indication Dec 2014; carcinoid syndrome indicationEU/EEAApproved: acromegaly, GEP-NETs,TSH-secreting pituitary tumorsSOURCE / AS OFROW 2 / 2001UNITED KINGDOMApproved: same indicationsSOURCE / AS OFROW 3 / 2001OTHER DOCUMENTEDSOURCE ROW OMITTEDSEE AUDIT REASONSOURCE / AS OFNOT PRESENT / NOT RECORDEDSPORT STATUS — SEPARATE FROM MEDICINE AUTHORIZATIONWADA: Not prohibited.
Authorization belongs to the named product, use, place, and date; sport status is independent.
بديل نصي
UNITED STATES
US (FDA): Approved: acromegaly, GEP-NETs (unresectable, well- or moderately differentiated, locally advanced or metastatic), carcinoid syndrome
EU/EEA
EU/EEA (EMA): Approved: acromegaly, GEP-NETs, TSH-secreting pituitary tumors
UNITED KINGDOM
UK (MHRA): Approved: same indications
OTHER DOCUMENTED
No OTHER DOCUMENTED row is present in the source status table

Sport status: WADA: Not prohibited.

Mechanism and pharmacology

Somatostatin receptor agonist with high affinity for SSTR2 (Kᵢ ~0.5–1.0 nM) and SSTR5 (Kᵢ ~0.5–1.0 nM); lower affinity for SSTR3. Inhibits GH and IGF-1 secretion, gastrointestinal peptide release, and tumor growth signaling. Suppresses TSH in TSH-secreting adenomas.

Evidence by claim

Claim/indicationStageGradeBest human evidenceMain resultImportant limitations
AcromegalyApprovedAPhase 3 and comparative studiesGH <2.5 ng/mL and normalized IGF-1 in ~60%Not -controlled in registration
(disease control)ApprovedACLARINET (Caplin M, et al. N Engl J Med. 2014;371:224–33. PMID: 25014687)Median PFS not reached vs 18 mo placebo (HR 0.47)Non-functioning tumors; Ki-67 <10%; placebo crossover permitted
Carcinoid syndromeApproved (US)AELECT (Vinik AI, et al. Endocr Relat Cancer. 2016;23(4):291–302. PMID: 26884601)49% reduction in octreotide rescue use (p=0.02)Rescue medication design limits interpretation
TSH-secreting pituitary tumorsApproved (EU)BCase seriesTSH suppression and tumor shrinkage reportedNo randomized trial
درجات الأدلة
  • Aالدرجة A: مثبت لاستخدام محدد مصرح به
  • Bالدرجة B: أدلة بشرية معتدلة
  • Cالدرجة C: أدلة بشرية أولية
  • Dالدرجة D: ما قبل السريرية فقط
  • Eالدرجة E: ادعاء قصصي/تسويقي
  • Xالدرجة X: الأدلة تتعارض مع الادعاء أو لا تدعمه
تعرف على المزيد حول تصنيف الأدلة
Claim-evidence profile
Lanreotide claim-evidence profileA: 3 claims; B: 1 claim; C: 0 claims; D: 0 claims; E: 0 claims; X: 0 claimsCONTRADICTORY / NON-SUPPORTIVEA — Established for a specific labeled useGrade A: Established for a specific labeled use — current approval plus adequate controlled trials and post-market context.3 claimsAcromegalyGEP-NET (disease control)+1 moreB — Moderate human evidenceGrade B: Moderate human evidence — multiple controlled studies or a strong pivotal study, but no current approval for the claim.1 claimTSH-secreting pituitary tumorsC — Preliminary human evidenceGrade C: Preliminary human evidence — small, uncontrolled, surrogate-endpoint, or early-phase studies.0 claimsD — Preclinical onlyGrade D: Preclinical only — in vitro or animal evidence with no adequate human efficacy evidence.0 claimsE — Anecdotal/marketing claimGrade E: Anecdotal/marketing claim — testimonials, extrapolation, or vendor claims without adequate scientific support.0 claimsX — Evidence contradicts or does not support the claimGrade X: Evidence contradicts or does not support the claim — adequate negative evidence, failed program, or claim inconsistent with the studied material.0 claims
This counts the page's claim rows; it does not average them into a score. All claims: Acromegaly; GEP-NET (disease control); Carcinoid syndrome; TSH-secreting pituitary tumors.
بديل نصي

Text alternative for the claim-evidence diagram. Each grade is defined below:

A — Established for a specific labeled use
3 claims: Acromegaly; GEP-NET (disease control); Carcinoid syndrome
B — Moderate human evidence
1 claim: TSH-secreting pituitary tumors
C — Preliminary human evidence
0 claims
D — Preclinical only
0 claims
E — Anecdotal/marketing claim
0 claims
X — Evidence contradicts or does not support the claim
0 claims
United StatesApproved: acromegaly, GEP-NETs (unresectable, well- or moderately differentiated, locally advanced or metastatic), carcinoid syndrome
EU/EEAApproved: acromegaly, GEP-NETs, TSH-secreting pituitary tumors
United KingdomApproved: same indications

Key studies

StudyDesign/populationExposure studiedEndpoints and resultLimitations
CLARINET, N=204, non-functioning (Ki-67 <10%)Lanreotide Autogel 120 mg deep q4wk vs Median PFS not reached vs 18 mo (HR 0.47, p=0.001)Few pancreatic NETs; no active comparator
ELECTRCT, N=115, carcinoid syndromeLanreotide Depot 120 mg deep SC q4wk vs placebo49% reduction in octreotide rescue use (p=0.02)Rescue medication design limits interpretation

Dose and administration evidence

Approved labeled regimen

The label summary below is product-, indication-, and jurisdiction-specific; consult the full current label and a licensed clinician/pharmacist.

Acromegaly — 90 mg deep q4wk initially, titrated based on GH/IGF-1 (range 60–120 mg). The labeled starting dose is 90 mg; the 60–120 mg range reflects dose adjustments, not the full approved range. — 120 mg deep SC q4wk. Carcinoid syndrome — 120 mg deep SC q4wk. Administered into the superior external gluteal area by a healthcare professional.

Studied regimens (not recommendations)

  • CLARINET: lanreotide Autogel 120 mg deep SC q4wk.

  • ELECT: lanreotide Depot 120 mg deep SC q4wk.

What is not established

  • Efficacy in high-grade (Ki-67 >20%) or poorly differentiated NET.

  • Benefit in functioning pancreatic NET not evaluated in CLARINET.

  • No established role outside approved indications.

Safety

Established label risks

  • Gallbladder: Cholelithiasis (class effect). Monitoring recommended.

  • Metabolic: Hyper-/hypoglycemia.

  • Cardiovascular: Sinus bradycardia, QT prolongation risk.

  • GI: Diarrhea, nausea, steatorrhea.

  • Injection site: Pain, granuloma, abscess.

  • Other: Vitamin B12 decrease; mild TSH suppression.

Human-study signals

  • CLARINET: diarrhea 26%, cholelithiasis 10%, abdominal pain 14%.

Unknowns and product-quality risks

  • Long-term safety >2 years in NETs from controlled data.

  • No pediatric safety established.

  • Research-grade vials may not replicate Autogel formulation.

Interactions and special populations

  • Additive bradycardia with beta-blockers, CCBs.

  • May alter glucose control medications requirements.

  • No dose adjustment needed in renal impairment; hepatic impairment data limited.

Regulatory, compounding, and sport notes

Evidence gaps

  • Head-to-head comparison with octreotide LAR for NET disease control.

  • Efficacy in high-grade NETs.

  • Long-term safety and tolerability beyond 2 years.

Search notes

Sources

  1. Somatuline Depot (lanreotide) prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e4a41fd-a753-4362-87ee-8cc56ed3660d

  2. Caplin ME, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors (CLARINET). N Engl J Med. 2014;371(3):224–33. PMID: 25014687.

  3. Electronic Medicines Compendium (UK). Somatuline Autogel 60 mg, 90 mg, 120 mg solution for injection in a pre-filled syringe (SmPC). https://www.medicines.org.uk/emc/product/8258/smpc

  4. PubChem. Lanreotide. https://pubchem.ncbi.nlm.nih.gov/compound/6918011

  5. Vinik AI, et al. ELECT study: lanreotide for carcinoid syndrome. Endocr Relat Cancer. 2016;23(4):291–302. PMID: 26884601.

أصوات الخبراء

ماذا يقول الخبراء

التعليقات آراء شخصية وليست جزءًا من مراجعة الأدلة؛ والإدراج لا يعني المصادقة.

لم يتم العثور على تعليقات خبراء موثقة لهذا المركب في المصادر التي يقبلها هذا الأطلس — الأدبيات المحكمة، واتصالات الجامعات والمستشفيات والجمعيات الطبية، والجهات التنظيمية، والصحافة العلمية الموقعة.

غياب التعليقات ليس دلياً على المركب بأي من الاتجاهين.

ادعاءات البائعين والعيادات ووسائل التواصل الاجتماعي مستبعدة بموجب السياسة ولا تُحتسب كتعليقات.

لم يتم العثور على فيديوهات خبراء موثقة لهذا المركب في مصادر هذا الأطلس.

غياب فيديوهات الخبراء ليس دلياً على المركب بأي من الاتجاهين.

فيديوهات البائعين ووسائل التواصل الاجتماعي مستبعدة بموجب السياسة ولا تُحتسب.

أسئلة

What is lanreotide?

Lanreotide is a synthetic octapeptide somatostatin analog with SSTR2 and SSTR5 affinity comparable to octreotide. It is formulated as a ready-to-use depot (Autogel).

Is lanreotide FDA-approved?

Yes. Lanreotide (Somatuline Depot) is FDA-approved for acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. The summary states EMA approval for the same indications, but the jurisdiction table lists EMA approval only for acromegaly, GEP-NETs, and TSH-secreting pituitary tumors; carcinoid syndrome is not listed under EMA.

What does the CLARINET study show for lanreotide in NETs?

The CLARINET trial (Caplin M, et al. N Engl J Med. 2014, PMID: 25014687) enrolled 204 patients with non-functioning GEP-NETs. Lanreotide Autogel improved median PFS (not reached vs 18 months placebo; HR 0.47, p=0.001). Limitations include few pancreatic NETs and no active comparator.

Is lanreotide the same as octreotide?

No. Lanreotide is a distinct octapeptide from octreotide, with D-Nal and Val substitutions and a different sequence. Both are somatostatin analogues with SSTR2 and SSTR5 affinity, but their products and labeled regimens differ.

What are lanreotide's main safety signals?

As a class effect of somatostatin analogs, cholelithiasis requires monitoring. Other risks include hyper- and hypoglycemia, sinus bradycardia, QT prolongation, gastrointestinal effects (diarrhea, nausea, steatorrhea), and local site reactions. The CLARINET study reported diarrhea 26%, cholelithiasis 10%, and abdominal pain 14%.

Is lanreotide prohibited in sport?

No. Lanreotide is not prohibited by WADA according to the 2026 Prohibited List. It is also not scheduled under the US Controlled Substances Act.

ذو صلة

الفئة: الجهاز الهضمي والغدد الصماء والقلب والأوعية الدمويةالسابق: Octreotideالتالي: Pasireotideملخصات اللوائح ذات الصلةأدلة الجرعات
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