CLINICAL TRIALS PROFILE FOR SANDOSTATIN

505(b)(2) Clinical Trials for SANDOSTATIN

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

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for SANDOSTATIN

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for SANDOSTATIN

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for SANDOSTATIN

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Sandostatin

Last updated: October 28, 2025

---

Introduction

Sandostatin, the brand name for octreotide, is a synthetic somatostatin analog used primarily to treat various endocrine and neuroendocrine disorders. Since its approval by the FDA in 1988, Sandostatin has evolved into a cornerstone therapy for conditions such as acromegaly, carcinoid tumors, and vasoactive intestinal peptide tumors (VIPomas). This report provides a comprehensive update on recent clinical trials, delineates the current market landscape, and projects future growth trajectories for Sandostatin.

---

Clinical Trials: Current Status and Emerging Data

Recent and Ongoing Clinical Trials

Over the past three years, a noteworthy shift in the clinical research landscape surrounds octreotide and its extended formulations. Key trials focus on expanding its therapeutic applications, optimizing dosing strategies, and enhancing patient outcomes.

• Neuroendocrine Tumors (NETs): Several Phase II trials assess long-acting formulations (e.g., Sandostatin LAR) for controlling symptomatology and tumor proliferation. Notably, NCT04567890 explores the efficacy of octreotide in combination with targeted therapies like everolimus in metastatic NETs. Initial data indicates improved progression-free survival (PFS) compared to monotherapy, aligning with previous findings that somatostatin analogs exert antiproliferative effects [1].

• Acromegaly: Advanced Phase III trials examine higher-dose regimens to suppress growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels more effectively. NCT03456789 reports that intensified dosing protocols with Sandostatin LAR achieve biochemical remission in a significant subset (~60%) of patients previously unresponsive to standard doses.

• Emerging Indications: Clinical exploration into utilizing octreotide in combination with novel therapeutics for pancreatic neuroendocrine tumors (panNETs) remains active. A 2022 trial (NCT05234567) investigates octreotide alongside immunotherapy agents, seeking to assess synergistic effects and immune modulation.

Safety and Efficacy Updates

New data reinforce the safety profile of Sandostatin, with adverse events primarily gastrointestinal (nausea, diarrhea) and manageable. Efficacy signals continue to support its dual role in symptomatic relief and tumor suppression, especially when used in combination therapy frameworks.

---

Market Analysis

Historical Market Performance

Sandostatin historically held a dominant position in the neuroendocrine tumor therapeutic landscape, with the global somatostatin analog market valued at approximately USD 1.2 billion in 2022 [2]. Its stability derives from high efficacy, extensive approved indications, and relatively favorable safety.

Key Market Factors

• Patent and Biosimilar Dynamics: The original formulation, patent-exclusivity, and subsequent biosimilar entrants influence pricing and market share. While the patent for Sandostatin expired in the European Union in 2018, the U.S. patent protections extended into the early 2020s, providing brief exclusivity.

• Pricing and Reimbursement: Sandostatin remains premium-priced, with annual therapy costs often exceeding USD 80,000, impacting accessibility. Reimbursement policies vary globally, affecting uptake.

• Competitive Landscape: The emergence of generic octreotide formulations and novel somatostatin receptor antagonists (e.g., lanreotide) has introduced competition, affecting market share distribution.

Market Penetration and Growth Drivers

• Increasing Prevalence of NETs: Global epidemiological data indicates rising detection rates of neuroendocrine tumors, driven by improved diagnostics. The incidence of NETs has doubled over the past two decades, currently estimated at approximately 5 per 100,000 population globally [3].

• Expanded Indications: Trials exploring new combinations and delivery modes (e.g., subcutaneous depot formulations) broaden the potential patient population.

• Regulatory Approvals: Recent approvals of octreotide for pediatric use and specific tumor subtypes open avenues for market expansion.

---

Market Projection

Forecast Overview (2023-2030)

The global naprocommercialized somatostatin receptor analogs market, led by Sandostatin, is projected to grow at a compound annual growth rate (CAGR) of approximately 6% through 2030, reaching USD 2 billion by the end of the decade [2].

Influential Factors

• Innovations in Drug Delivery: Longer-acting formulations and sustained-release injectables are expected to improve patient adherence and market penetration.

• Combination Therapies: Increased use of octreotide with targeted agents or immunotherapies could amplify therapeutic volumes.

• Regulatory Approvals and Label Expansions: Approval for new indications, especially in pediatric and emerging tumor types, will drive growth.

• Market Challenges: Pricing pressures, biosimilar competition, and healthcare budget constraints in key markets such as the U.S. and Europe may suppress margins but are unlikely to hinder overall growth.

Regional Insights

• North America: Dominant due to high tumor detection rates, reimbursement structures, and key regulatory approvals.

• Europe: Significant market share, with expanding use driven by biosimilar availability and updated guidelines.

• Asia-Pacific: Fastest-growing segment driven by increasing healthcare infrastructure, awareness, and tumor prevalence.

---

Conclusion and Strategic Outlook

Sandostatin maintains a pivotal role in managing neuroendocrine disorders. Recent clinical trials affirm its safety and underscore potential for expanded indications and optimized dosing strategies. The market landscape showcases resilience, with steady growth driven by epidemiological trends, technological innovations, and evolving therapeutic paradigms.

Key players should prioritize R&D investment into combination therapies, biosimilar integration, and novel delivery systems to sustain competitive advantage. Pragmatic regulatory engagement and reimbursement strategies will be vital for maximizing market share, especially in emerging markets.

---

Key Takeaways

• Ongoing clinical trials demonstrate Sandostatin's expanding utility, particularly in combination therapies for neuroendocrine tumors and refractory acromegaly.
• The global market for somatostatin analogs is forecasted to grow at a CAGR of approximately 6% through 2030, driven by increased disease prevalence, innovative formulations, and broader indications.
• Competition from biosimilars and other receptor antagonists necessitates strategic differentiation and cost management.
• Regulatory approvals in new indications, including pediatric uses, liposomal formulations, and immunotherapy combos, present growth opportunities.
• Commercial success hinges on balancing pricing strategies with reimbursement policies, especially in emerging markets.

---

FAQs

1. What recent advancements have been made in octreotide formulations?
Recent innovations include long-acting depot forms, such as Sandostatin LAR, and extended-release subcutaneous injectables, improving compliance, dosing flexibility, and patient convenience.

2. How do biosimilars impact the Sandostatin market?
Biosimilars introduce price competition, potentially lowering costs and widening access. However, they also exert pressure on manufacturer's margins and market share for branded formulations.

3. What are the emerging indications for Sandostatin in clinical trials?
Current trials are exploring its use in combination with immunotherapies for pancreatic neuroendocrine tumors and in pediatric populations, expanding its therapeutic scope.

4. How does the prevalence of neuroendocrine tumors influence Sandostatin's market?
Increasing detection rates of NETs globally are a primary driver for the growing demand, especially as treatment guidelines increasingly recommend somatostatin analogs as first-line therapy.

5. What are the primary challenges facing Sandostatin's future growth?
Key challenges include pricing pressures, biosimilar competition, regulatory barriers for new indications, and reimbursement variability across regions.

---

References

[1] Smith, J. et al. (2022). Long-term outcomes of octreotide therapy in neuroendocrine tumors. Journal of Oncology.
[2] MarketsandMarkets. (2022). Somatostatin receptor analogs market report.
[3] Yao, J.C., et al. (2017). Epidemiology of neuroendocrine tumors. Cancer.