CLINICAL TRIALS PROFILE FOR SANDOSTATIN LAR

505(b)(2) Clinical Trials for SANDOSTATIN LAR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Novartis	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
New Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Guangdong General Hospital	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
New Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Guangdong Provincial People's Hospital	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.

All Clinical Trials for SANDOSTATIN LAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001860 ↗	Sandostatin LAR Depot vs. Surgery for Treating Acromegaly	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	1999-08-01	The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
NCT00002252 ↗	A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea	Completed	Sandoz	N/A	1969-12-31	To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
NCT00002253 ↗	A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Co	Completed	Sandoz	N/A	1969-12-31	The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA 102A). The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders" from Study #D03 - FDA 102A.
NCT00002779 ↗	Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1998-02-01	RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkin's lymphoma.
NCT00002779 ↗	Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1998-02-01	RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkin's lymphoma.

Clinical Trial Conditions for SANDOSTATIN LAR

Condition Name

Condition Name for SANDOSTATIN LAR
Intervention	Trials
Acromegaly	18
Neuroendocrine Tumors	6
Carcinoid Tumor	4
Diarrhea	4

Condition MeSH

Condition MeSH for SANDOSTATIN LAR
Intervention	Trials
Acromegaly	18
Neuroendocrine Tumors	17
Carcinoid Tumor	15
Neoplasms	11

Clinical Trial Locations for SANDOSTATIN LAR

Trials by Country

Trials by Country for SANDOSTATIN LAR
Location	Trials
United States	284
Netherlands	15
Canada	14
Spain	12
Italy	8

Trials by US State

Trials by US State for SANDOSTATIN LAR
Location	Trials
California	14
New York	13
Michigan	12
Florida	12
Massachusetts	11

Clinical Trial Progress for SANDOSTATIN LAR

Clinical Trial Phase

Clinical Trial Phase for SANDOSTATIN LAR
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	13
Phase 3	9

Clinical Trial Status

Clinical Trial Status for SANDOSTATIN LAR
Clinical Trial Phase	Trials
Completed	48
Terminated	9
Unknown status	7

Clinical Trial Sponsors for SANDOSTATIN LAR

Sponsor Name

Sponsor Name for SANDOSTATIN LAR
Sponsor	Trials
Novartis	13
National Cancer Institute (NCI)	10
Novartis Pharmaceuticals	6

Sponsor Type

Sponsor Type for SANDOSTATIN LAR
Sponsor	Trials
Other	85
Industry	37
NIH	15

Clinical Trials Update, Market Analysis, and Projection for Sandostatin Lar

Last updated: October 28, 2025

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Introduction

Sandostatin Lar, a long-acting formulation of octreotide, plays a pivotal role in the management of neuroendocrine tumors (NETs) and acromegaly. Approved by the FDA in 2009, it offers sustained receptor binding, reducing the frequency of injections from multiple daily doses to once every four weeks. As the landscape of endocrine and neuroendocrine therapies evolves, comprehending the latest clinical trial developments, market trajectory, and future potential of Sandostatin Lar is crucial for stakeholders. This analysis synthesizes current clinical trial activity, evaluates market dynamics, and projects future growth trajectories.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

The clinical research landscape for Sandostatin Lar focuses predominantly on expanding indications, enhancing efficacy, and evaluating combination therapies.

• New Indication Investigations: Recent trials explore its utility beyond neuroendocrine tumors and acromegaly, including gastrinoma, VIPoma, and bronchial carcinoids. For instance, a Phase II trial (NCT04523277) is assessing its efficacy in controlling symptoms in patients with metastatic small-cell lung cancer (SCLC), aiming to extend its application spectrum.

• Combination Therapy Trials: Studies are evaluating Sandostatin Lar combined with targeted agents such as everolimus (NCT02931994), aiming to improve outcomes for progressive NETs. Results are anticipated in the coming years, potentially establishing its role in combination regimens.

• Biomarker and Pharmacokinetic Studies: Trials like NCT04175678 investigate biomarkers that predict response, enhancing patient selection and personalizing treatment approaches.

Clinical Trial Outcomes and Implications

While conclusive data is pending, early-phase results underline its tolerability and sustained symptom control. A retrospective analysis published in The Journal of Clinical Endocrinology & Metabolism (2022) confirmed durable tumor stabilization in a significant subset of NET patients, aligning with prior findings that underscore its efficacy.

Regulatory and Approval Status

Sandostatin Lar remains primarily approved for neuroendocrine tumors and acromegaly. Ongoing trials testing off-label indications may influence future regulatory decisions, contingent on positive trial outcomes and safety profiles.

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Market Analysis

Market Overview

The global neuroendocrine tumor (NET) therapeutics market was valued at approximately USD 750 million in 2022, with an anticipated compound annual growth rate (CAGR) of around 9.2% through to 2030 [1]. Sandostatin Lar, as a leading long-acting somatostatin analog (SSA), accounts for a substantial share due to its established efficacy and patient compliance benefits.

Competitive Landscape

Major competitors include:

• Somatuline Depot (Lanreotide): Approved for similar indications, offering comparable long-acting effects.
• Pasireotide (Signifor LAR): Targets acromegaly and Cushing’s disease, with some overlapping indications.
• Emerging Biologics & Peptides: Research into novel receptor-targeted therapies may reshape competition in future.

AbbVie, the manufacturer of Sandostatin Lar, maintains a strategic advantage owing to its early market entry and expansive clinical data set.

Market Drivers

Key factors driving growth include:

• Rising Incidence of NETs: An increased diagnosis rate, driven by advanced imaging and biomarker identification, enlarges the patient pool.
• Longevity and Quality of Life: The drug’s ability to suppress hormone-related symptoms enhances patient quality of life, reinforcing adherence.
• Regulatory Approvals in Emerging Markets: Expanding approval landscape across Asia-Pacific, Latin America, and the Middle East opens new revenue streams.

Market Challenges

• Generic Competition: Patent expirations and biosimilar entrants in certain regions may pressure pricing.
• Pricing and Reimbursement Dynamics: Varies globally, impacting market penetration.
• Limitations in Indication Expansion: Clinical trial setbacks could restrict growth opportunities.

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Market Projection and Future Outlook

Growth Forecasts (2023-2030)

Analysts project a steady CAGR of approximately 8-10% for Sandostatin Lar and the broader long-acting SSA market, driven predominantly by increased NET diagnosis rates and ongoing trials for novel indications [2].

• Short-term (2023-2025): Growth fueled by existing approved uses, with expansions into rare NET subtypes gaining momentum.
• Medium-term (2026-2028): Potential approvals for additional indications, especially if ongoing trials demonstrate efficacy.
• Long-term (2029-2030): Market saturation may occur in core indications, but niche therapies and combination regimens could sustain growth.

Innovative Developments

Emerging innovations such as octreotide biosimilars, improved drug delivery systems, and personalized medicine approaches are poised to influence the competitive landscape, potentially reducing costs and enlarging access.

Regulatory and Market Access Strategies

Strategic partnerships with regional distributors, early engagement with regulatory authorities, and inclusion in clinical guidelines will be key to sustaining and expanding market share.

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Key Takeaways

• Clinical Trial Progress: Active research into new indications and combination therapies signifies ongoing innovation, which could expand Sandostatin Lar’s application scope.
• Market Position & Growth: Its foundational role in NET treatment sustains strong market demand, expected to grow at a robust CAGR through 2030.
• Competitive Landscape: While facing competition from similar long-acting SSAs, brand recognition, established efficacy, and ongoing trials support its enduring position.
• Challenges & Opportunities: Patent expirations and biosimilar entry may challenge pricing, but expanding indications and emerging markets offer growth avenues.
• Strategic Focus: Emphasizing clinical trial outcomes, regulatory engagement, and geographic expansion will be essential for stakeholders to capitalize on market opportunities.

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FAQs

1. What are the primary approved indications for Sandostatin Lar?

Sandostatin Lar is approved for treating neuroendocrine tumors, acromegaly, and conditions associated with hormone hypersecretion, such as carcinoid syndrome [3].

2. How does Sandostatin Lar compare to other long-acting SSAs?

Sandostatin Lar offers once-monthly injection convenience with a well-established efficacy profile. Its pharmacokinetic properties enable sustained receptor engagement, comparable to Lanreotide (Somatuline Depot), though regional preferences and approval statuses vary.

3. Are there ongoing trials exploring new uses for Sandostatin Lar?

Yes, trials are investigating its potential in gastric, bronchial, and other neuroendocrine tumors, as well as combination therapies for enhanced efficacy.

4. What factors influence the market growth of Sandostatin Lar?

Incidence trends in NETs, global healthcare investments, regulatory approvals, and the development of biosimilars significantly impact growth potential.

5. What are the main challenges facing Sandostatin Lar's market sustainability?

Patent expirations, biosimilar price competition, and limited indication expansion due to clinical trial outcomes could impede its growth trajectory.

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References

[1] MarketsandMarkets. "Neuroendocrine Tumors Therapeutics Market." 2022.

[2] Grand View Research. "Long-Acting Somatostatin Analog Market Trends." 2023.

[3] FDA. "Sandostatin (octreotide) Prescribing Information." 2021.

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This comprehensive overview facilitates strategic decision-making for industry professionals, highlighting clinical developments, market forces, and future opportunities surrounding Sandostatin Lar.