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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR SOMATULINE DEPOT


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All Clinical Trials for Somatuline Depot

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00149188 ↗ Somatuline Autogel: Acromegaly Self/Partner Injection Study Completed Ipsen Phase 4 2004-02-01 The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.
NCT00216398 ↗ Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR Completed Ipsen Phase 4 2004-06-01 The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
NCT00288522 ↗ Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment Terminated Ipsen Phase 2 2006-01-01 The main purpose of this study is to evaluate the efficacy and safety of 3 doses of Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.
NCT00444873 ↗ Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly Completed Ipsen Phase 3 2005-01-01 A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Somatuline Depot

Condition Name

Condition Name for Somatuline Depot
Intervention Trials
Acromegaly 9
NeuroEndocrine Tumours 2
Neuroendocrine Tumors 2
Neuroendocrine Tumors in Lung 1
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Condition MeSH

Condition MeSH for Somatuline Depot
Intervention Trials
Acromegaly 9
Neuroendocrine Tumors 8
Carcinoid Tumor 7
Carcinoma 2
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Clinical Trial Locations for Somatuline Depot

Trials by Country

Trials by Country for Somatuline Depot
Location Trials
United States 44
Belgium 10
Netherlands 8
United Kingdom 6
Canada 5
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Trials by US State

Trials by US State for Somatuline Depot
Location Trials
California 6
Oregon 3
New York 3
Maryland 3
Colorado 3
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Clinical Trial Progress for Somatuline Depot

Clinical Trial Phase

Clinical Trial Phase for Somatuline Depot
Clinical Trial Phase Trials
Phase 4 6
Phase 3 8
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Somatuline Depot
Clinical Trial Phase Trials
Completed 13
Terminated 4
Unknown status 3
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Clinical Trial Sponsors for Somatuline Depot

Sponsor Name

Sponsor Name for Somatuline Depot
Sponsor Trials
Ipsen 19
Radboud University 2
Erasmus Medical Center 2
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Sponsor Type

Sponsor Type for Somatuline Depot
Sponsor Trials
Other 28
Industry 19
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Clinical Trials, Market Analysis, and Projections for SOMATULINE DEPOT

Introduction to SOMATULINE DEPOT

SOMATULINE DEPOT, also known as lanreotide acetate, is a somatostatin analog used in the treatment of various conditions, including acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Acromegaly

Clinical trials for SOMATULINE DEPOT in acromegaly have been extensive. In these studies, patients received SOMATULINE DEPOT at doses of 60, 90, or 120 mg every 4 weeks via deep subcutaneous injection. The primary goal was to reduce serum growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels to normal.

  • Efficacy: Studies showed that SOMATULINE DEPOT effectively reduced GH and IGF-1 levels. For example, in one study, 69% of patients had serum GH levels less than 10 ng/mL, and 31% had levels of 10 ng/mL or greater at baseline[1][3].
  • Adverse Reactions: Common adverse reactions included gastrointestinal disorders (diarrhea, abdominal pain, nausea), cholelithiasis, and injection site reactions. These reactions were generally mild to moderate in severity[1][3].

GEP-NETs and Carcinoid Syndrome

For GEP-NETs and carcinoid syndrome, SOMATULINE DEPOT is administered at a dose of 120 mg every 4 weeks.

  • Efficacy: In clinical trials, SOMATULINE DEPOT demonstrated efficacy in slowing the growth of GEP-NETs and reducing the need for short-acting somatostatin medications in carcinoid syndrome. For instance, in a study involving patients with GEP-NETs, 81% of patients did not experience disease progression within 6 months of enrollment[1][5].
  • Adverse Reactions: The adverse reaction profile was similar to that observed in acromegaly patients, with gastrointestinal disorders and cholelithiasis being prominent[1][3].

Market Analysis

Current Market Landscape

The acromegaly therapeutics market is dominated by somatostatin analogs (SSAs), growth hormone receptor antagonists (GHRAs), and dopamine agonists. As of 2018, the total market valuation for SSAs was approximately USD 782.87 million, with GHRAs at USD 199.07 million and dopamine agonists at USD 34.94 million[2].

  • SOMATULINE DEPOT Market Share: SOMATULINE DEPOT is a significant player in the SSA segment. It is approved in the US for the long-term treatment of acromegaly and is covered under Medicare Part B and Part D, as well as by most state Medicaid programs[2].

Market Projections

The acromegaly therapeutics market is expected to grow, driven by increasing prevalence and the introduction of new therapies.

  • Growth Rate: The market is projected to grow with a Compound Annual Growth Rate (CAGR) of 5.69% from 2018 to 2030. This growth is attributed to the increasing demand for effective treatments and the expanding pipeline of new therapies[2].
  • Revenue Projections: Mycapssa (Octreotide Capsules), another SSA, is expected to reach up to USD 450 million in the seven major markets by the end of the forecast period. Similar growth is anticipated for SOMATULINE DEPOT, given its established presence and ongoing innovations[2].

Innovations and Future Developments

New Electronic Autoinjector

Ipsen, the manufacturer of SOMATULINE DEPOT, has announced an investment in a new state-of-the-art electronic autoinjector designed to improve patient experience. This device, developed in collaboration with Phillips-Medisize, aims to enhance administration and reduce injection-site pain. Clinical studies evaluating the performance and safety of this new device are ongoing, with the device expected to be available to patients in 2024[4].

Patient Experience and Compliance

The introduction of the new autoinjector is expected to improve patient compliance and satisfaction. Studies assessing patient-reported outcomes and device safety will provide valuable insights into the effectiveness of this innovation.

Reimbursement and Access

Medicare and Medicaid Coverage

SOMATULINE DEPOT is covered under Medicare Part B when administered by a healthcare provider and under Part D when dispensed in an outpatient setting. It is also reimbursed by most state Medicaid programs, although coverage and payment vary by state[2].

Key Takeaways

  • Clinical Efficacy: SOMATULINE DEPOT has demonstrated efficacy in reducing GH and IGF-1 levels in acromegaly and in managing GEP-NETs and carcinoid syndrome.
  • Adverse Reactions: Common adverse reactions include gastrointestinal disorders, cholelithiasis, and injection site reactions.
  • Market Growth: The acromegaly therapeutics market is expected to grow with a CAGR of 5.69% from 2018 to 2030.
  • Innovations: The introduction of a new electronic autoinjector aims to improve patient experience and compliance.
  • Reimbursement: SOMATULINE DEPOT is covered by Medicare and most state Medicaid programs.

FAQs

What is SOMATULINE DEPOT used for?

SOMATULINE DEPOT is used for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.

What are the common adverse reactions associated with SOMATULINE DEPOT?

Common adverse reactions include gastrointestinal disorders (diarrhea, abdominal pain, nausea), cholelithiasis, and injection site reactions.

Is SOMATULINE DEPOT covered by insurance?

Yes, SOMATULINE DEPOT is covered under Medicare Part B and Part D, as well as by most state Medicaid programs.

What is the expected market growth for acromegaly therapeutics?

The acromegaly therapeutics market is expected to grow with a CAGR of 5.69% from 2018 to 2030.

What innovations are being introduced for SOMATULINE DEPOT?

A new state-of-the-art electronic autoinjector is being developed to improve patient experience and reduce injection-site pain.

Sources

  1. Somatuline Depot USPI Feb 2023 - Ipsen.
  2. Acromegaly Therapeutics Market Expected to Increase with CAGR of 5.69 Throughout the Study Period 2018-2030 - DelveInsight.
  3. Somatuline Depot - Cloudfront.net.
  4. Ipsen Announces Investment in New State-of-the-Art Electronic Autoinjector for Somatuline Autogel / Somatuline Depot - Ipsen.
  5. MAKE TODAY A TURNING POINT - Somatuline Depot Digital Patient Education Brochure - Ipsen.
Last updated: 2024-12-31

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