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.

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

Sandostatin (octreotide) Clinical Trials Update, Market Analysis, and Projections

Last updated: April 28, 2026

What is Sandostatin and what products drive sales?

Sandostatin is a branded form of octreotide (somatostatin analog). The commercial footprint is driven by long-acting formulations used across endocrine and GI tumor indications.

Key marketed product types by typical chronic-use pattern

• Sandostatin LAR (octreotide acetate for depot injection): monthly dosing, core revenue driver for neuroendocrine tumor (NET) care.
• Sandostatin (octreotide acetate injection): typically short-acting use (acute control settings, bridging, and certain special scenarios).

Market and competitive intensity largely track NET incidence, treatment guideline adoption, payer coverage, and comparative durability versus next-generation somatostatin analogs and targeted therapies.

What is the clinical trial update for octreotide (Sandostatin) in NET and related indications?

A complete, line-by-line “trial update” for Sandostatin requires trial-by-trial status data (registrations, start/completion dates, results posted, and comparative endpoints). That level of granularity is not available in the provided input. Under this constraint, only high-confidence, category-level clinical positioning can be stated without fabricating trial statuses.

Clinical positioning that stays stable across recent years

• Octreotide (Sandostatin) remains a standard somatostatin receptor-targeted therapy for NETs, especially where SSA monotherapy or SSA maintenance is used.
• Treatment selection typically depends on tumor grading, receptor expression, prior therapies, and symptom control needs.

Practical implication for R&D and investment

• Octreotide’s development risk profile is low for label expansion compared with novel agents, but incremental value creation often depends on new combinations, sequence optimization, and biomarker-linked selection rather than wholly new mechanisms.

How big is the Sandostatin opportunity and where does growth come from?

Without a source-linked numeric market dataset in the provided input, projecting exact revenues or TAM requires external market research inputs. Under this constraint, this report focuses on demand drivers and category dynamics that determine Sandostatin’s market trajectory.

Demand drivers

1. NET incidence and survival gains
   • More diagnosis and longer survival increase lifetime SSA treatment duration.
2. Payer preference for established, guideline-listed SSAs
   • Octreotide’s long track record supports formulary placement.
3. Symptom control and disease stabilization use-cases
   • SSAs are used for functional symptom management and radiographic control, which sustains recurring dosing.

Competitive and substitution forces

1. Somatostatin analog competition
   • Other SSAs (e.g., long-acting alternatives) compete on dose schedule, tolerability, and payer contracting.
2. Targeted and radioligand therapies
   • Newer NET therapies can reduce SSA share at later lines, but SSAs still occupy early lines and maintenance in many care pathways.

What is the market projection framework for Sandostatin?

A credible projection for Sandostatin must model:

• Patient population: diagnosed NET and related endocrine indications
• Line-of-therapy distribution: SSA share in each line
• Duration on therapy: time on treatment, dose interval patterns
• Pricing and reimbursement trajectory: US WAC to net price conversion effects, biosimilar/generic substitution risk, and contract dynamics
• Competition and sequencing: targeted therapy and radioligand uptake rates

With no market dataset supplied, a numeric forecast cannot be produced without inventing inputs. The projection below therefore states the directional outcomes that typically determine whether Sandostatin’s revenue rises or compresses.

Base-case directional projection (directional, not numeric)

• Modest growth is the most likely outcome if NET incidence and treatment duration expand faster than substitution.
• Share pressure is likely if payer policies shift toward alternative SSAs or if targeted/radioligand sequences displace octreotide earlier.

Downside case

• Faster uptake of alternative SSAs or non-SSA NET regimens in earlier lines can reduce octreotide’s treated- patient count and shift octreotide to fewer lines.

Upside case

• Stronger guideline adherence to SSA-based strategies, plus durable maintenance use, can extend patient duration and stabilize share even as oncology innovations expand.

Where does Sandostatin sit versus key alternatives in NET treatment?

Octreotide competes within a crowded NET landscape that includes other SSAs and oncology modalities. The competitive question for investors and R&D planners is not only mechanism, but how care pathways actually sequence therapies.

Competitive categories

• Other somatostatin analogs (long-acting injections)
• Targeted systemic therapies (varies by NET subtype and line)
• Radioligand therapy (especially for receptor-positive disease)
• Chemotherapy for certain high-burden or rapidly progressive settings

Octreotide’s strength typically remains:

• Established clinical use
• Long-acting depot delivery
• Predictable dosing and clinician familiarity
• Broad applicability in receptor-positive NET management

What should R&D planners look for in future octreotide value creation?

Even without a trial-by-trial update, octreotide’s value creation typically comes from where evidence gaps remain:

• Combination regimens that improve progression-free outcomes or extend time-to-next-therapy
• Biomarker-driven selection (somatostatin receptor profiling to identify responders)
• Sequence optimization across line-of-therapy to maintain SSA utility before or after targeted/radioligand therapies
• Adherence and dosing convenience improvements within the long-acting format class

Commercial watchpoints for investors

1) Formulary and contracting

• Cementing access for Sandostatin LAR is usually more important than marginal label changes.

2) Competitive tender outcomes

• Long-acting SSAs often face procurement pressure. A one-contract shift can materially change monthly-treated share.

3) Biosimilar or generic erosion risk

• Any increased competitive pressure on depot octreotide formulations can compress net pricing.

4) Guideline updates

• Guideline positioning affects initiation rates and duration on SSA therapy.

Market data required for numeric forecasts

A numeric market projection for Sandostatin requires:

• Recent global and US sales by Sandostatin LAR and short-acting octreotide
• NET treated population trend and SSA share by line
• Pricing trajectory and expected competitive impact
• Clinical adoption curves for competing therapies

Those inputs are not present in the provided prompt, so this report does not provide revenue figures or point forecasts.

Key Takeaways

• Sandostatin (octreotide) remains anchored in NET care with Sandostatin LAR as the core chronic-use product.
• A fully detailed clinical trials update by trial status cannot be produced from the provided information without risking fabrication.
• Directionally, the opportunity depends on NET incidence growth, time-on-therapy, payer formulary stability, and competitive substitution by other SSAs and newer NET therapies.
• Future value creation is most likely to come from combination strategies, biomarker selection, and sequence optimization rather than major mechanism changes.

FAQs

1. Is Sandostatin still used in neuroendocrine tumors?
   Yes. Octreotide remains a standard somatostatin receptor-targeted therapy in NET care, particularly in SSA-based treatment strategies.

2. What is the main Sandostatin product driving revenue?
   Sandostatin LAR (long-acting depot octreotide) typically drives the chronic, recurring portion of demand for NET patients.

3. What could most reduce Sandostatin’s market growth?
   Early-line displacement via increased uptake of alternative SSAs and/or non-SSA NET therapies that change sequencing patterns.

4. What could most support Sandostatin’s market growth?
   Expansion in diagnosed patient volumes and durable maintenance use that sustains time on SSA therapy, supported by stable payer access.

5. Does octreotide face the same R&D risk as novel oncology drugs?
   Generally lower for label maintenance, because the mechanism and clinical use are established; incremental value tends to hinge on combinations, sequencing, and biomarkers.

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References

[1] No sources were provided in the input.