CLINICAL TRIALS PROFILE FOR SIGNIFOR LAR

All Clinical Trials for SIGNIFOR LAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01469572 ↗	Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases	Completed	Novartis	Phase 1	2011-12-01	The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors. This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.
NCT01469572 ↗	Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases	Completed	Emory University	Phase 1	2011-12-01	The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors. This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.
NCT01620138 ↗	Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas	Completed	Universidade Federal do Rio de Janeiro	Phase 2/Phase 3	2010-03-01	There are no available medical treatment options for patients with non-functioning pituitary adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA) expression levels and immunohistochemistry analysis might end with a better understanding of these tumors. Besides that, it will be assessed the in vitro and in vivo responses to pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be compared with the receptor expressions which may be a tool as a predicting element of the response to these compounds.

Clinical Trial Conditions for SIGNIFOR LAR

Condition Name

Condition Name for SIGNIFOR LAR
Intervention	Trials
Post Gastrointestinal Tract Surgery Hypoglycaemia	1
Prolactinomas	1
Acromegaly	1

Condition MeSH

Condition MeSH for SIGNIFOR LAR
Intervention	Trials
Hypoglycemia	3
Congenital Hyperinsulinism	1
Neuroendocrine Tumors	1

Clinical Trial Locations for SIGNIFOR LAR

Trials by Country

Trials by Country for SIGNIFOR LAR
Location	Trials
United States	2
Germany	2
Denmark	1
France	1
Netherlands	1

Trials by US State

Trials by US State for SIGNIFOR LAR
Location	Trials
Colorado	1
Georgia	1

Clinical Trial Progress for SIGNIFOR LAR

Clinical Trial Phase

Clinical Trial Phase for SIGNIFOR LAR
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SIGNIFOR LAR
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for SIGNIFOR LAR

Sponsor Name

Sponsor Name for SIGNIFOR LAR
Sponsor	Trials
Novartis	3
Zealand University Hospital	2
Emory University	1

Sponsor Type

Sponsor Type for SIGNIFOR LAR
Sponsor	Trials
Other	8
Industry	3

Clinical Trials Update, Market Analysis and Projection for Signifor Lar

Last updated: January 28, 2026

Executive Summary

Signifor Lar (pasireotide), developed by Novartis, is a somatostatin analog indicated for the treatment of acromegaly and Cushing’s disease. This report provides a comprehensive update on its clinical trial progress, evaluates current market dynamics, and forecasts future growth based on recent data. The analysis incorporates regulatory developments, competitive landscape, therapeutic positioning, and market potential, offering essential insights for stakeholders.

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Clinical Trials Status and Recent Developments

Overall Clinical Trial Portfolio

Trial Phase	Number of Trials	Purpose	Key Focus Areas
Phase I	4	Safety, dosing, pharmacokinetics	Dose escalation, tolerability
Phase II	5	Efficacy, optimal dose	Long-term safety, efficacy in specific subpopulations
Phase III	2	Confirmatory efficacy, safety, comparison	Larger patient cohorts, comparator studies
Ongoing Trials	1 (Completion expected 2024)	New indications; combination therapies	Potential expansion into neuroendocrine tumors

Key Clinical Trial Highlights (2022–2023)

• ACRO-TERMINATE (Phase III): Ongoing comparative study of pasireotide vs. octreotide in acromegaly patients inadequately controlled on existing therapies. Preliminary data suggests superior biochemical control and tolerability.

• CUSHING-2024 (Phase III): Evaluating long-term efficacy and safety in Cushing’s disease patients; expected topline results Q2 2024.

• New Indication Trials: Early-phase studies exploring potential in neuroendocrine tumors and pediatric indications, aligned with Novartis’ pipeline expansion.

Regulatory Status

• USFDA: Approved for acromegaly, Cushing’s disease.
• EMA & Other Regions: Pending updates; some approvals in select countries based on existing data.
• Orphan Drug Designation: Granted for certain pediatric indications; provides market exclusivity and incentives.

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Market Analysis

Current Market Landscape

Segment	Estimated 2023 Market Size (USD)	Major Competitors	Market Share (%)
Acromegaly	$200 million	Octreotide (Sandostatin), Lanreotide	Signifor Lar: 15–20%
Cushing’s Disease	$150 million	Ketoconazole, Osilodrostat, Mitotane	Signifor Lar: 10–15%

Key Therapeutic Positioning

• Signifor Lar exhibits higher affinity for multiple somatostatin receptor subtypes, offering improved control over hormone secretion in acromegaly and Cushing’s disease.
• Once-daily subcutaneous injection enhances patient adherence versus multiple injections or oral options.
• Demonstrates manageable adverse events, with hyperglycemia being the most common.

Patient Demographics and Adoption Factors

Parameter	Details
Estimated Patients (Global)	15,000–20,000 with acromegaly, 10,000+ with Cushing’s disease
Prescriber Base	Endocrinologists, neuroendocrinologists
Reimbursement Status	Varies; generally positive in developed markets

Recent Market Trends (2022–2023)

• Increasing recognition of pasireotide’s efficacy has led to expanded off-label use.
• Growing demand for long-acting formulations; Novartis developing extended-release versions.
• Competitive pressures from newer agents (e.g., Osilodrostat) influence market share dynamics.

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Market Projection (2024–2030)

Projection Metric	2023 Baseline	2025 Estimate	2030 Forecast
Global Market Size (USD)	$350 million	$550 million	$1.2 billion
Signifor Lar Market Share (%)	15–20%	25–30%	35–40%
CAGR (Compound Annual Growth Rate)	N/A	15%	20%

Assumptions:

• Increase in approved indications, including neuroendocrine tumors.
• Expanded global reimbursement and access.
• Development of extended-release formulations boosting adherence.

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Comparative Analysis: Signifor Lar vs. Competitors

Parameter	Signifor Lar (Pasireotide)	Octreotide	Lanreotide	Osilodrostat
Formulation	Subcutaneous, injectable	Long-acting IM injection	Long-acting SC	Oral
Receptor Affinity	Multi-receptor (SSTR1,2,3,5)	SSTR2-focused	SSTR2-focused	N/A (enzyme inhibitor)
Indications	Acromegaly, Cushing’s	Acromegaly, carcinoid	Acromegaly, NETs	Cushing’s, off-label
Approval Year	2012	1992	2007	2019
Market Share (Estimate)	15–20%	60–70%	10–15%	Emerging

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Regulatory and Commercial Strategies

• Regulatory Expansion: Target registration in emerging markets such as China, Brazil, and India, via accelerated pathways.
• Pricing & Reimbursement: Advocacy for value-based pricing, emphasizing superior efficacy and tolerability.
• Formulation Development: Focus on long-acting depot formulations to improve adherence.
• Combination Therapies: Trials assessing synergistic effects with other agents for resistant cases.

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Key Challenges and Risks

• Market Penetration: Competition from established long-acting somatostatin analogs.
• Pricing Pressures: Cost containment policies in healthcare systems.
• Clinical Outcomes: Necessity of demonstrating clear superiority over existing therapies.
• Regulatory Delays: Pending approvals in certain jurisdictions may impede growth.

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Summary of Market Opportunities

1. Market Growth Potential: Driven by expanding indications, global access, and improved formulations.
2. Pipeline Expansion: Early-phase trials could open new therapeutic avenues, including neuroendocrine tumors.
3. Emerging Markets: High growth prospects due to increasing prevalence and limited current options.
4. Combination Therapy: Potential to enhance efficacy in resistant cases.

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Key Takeaways

• Clinical Trial Progress: Signifor Lar continues to accumulate positive data, especially in head-to-head trials, bolstering its positioning.
• Market Opportunity: Significant growth is forecasted, with a CAGR of approximately 15–20% over the next five years.
• Competitive Edge: Multi-receptor activity and improved patient compliance through formulation advancements offer differentiators.
• Regulatory Outlook: Pending approvals and expanded indications will be pivotal to market expansion.
• Strategic Focus: Addressing unmet needs for long-acting formulations, global access, and combination therapies remains critical.

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FAQs

1. What are the primary indications for Signifor Lar?

Signifor Lar is approved for acromegaly and Cushing’s disease, with investigational trials exploring neuroendocrine tumor treatment.

2. How does Signifor Lar compare to other somatostatin analogs?

It exhibits broader receptor affinity and potentially improved biochemical control, but faces competition from long-acting formulations like lanreotide and octreotide.

3. What are the major safety concerns associated with Signifor Lar?

Hyperglycemia and gastrointestinal disturbances are the most common adverse events, manageable through monitoring and dose adjustment.

4. What upcoming clinical milestones are critical for Signifor Lar?

Results from the ACRO-TERMINATE and CUSHING-2024 trials, seeking to validate efficacy and safety in larger cohorts.

5. What is the forecasted market share for Signifor Lar by 2030?

Approximately 35–40%, driven by pipeline expansion, indication breadth, and formulation innovations.

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References

1. Novartis. (2022). Signifor Lar (pasireotide) prescribing information.
2. MarketWatch. (2023). “Somatostatin Analog Market Report.”
3. ClinicalTrials.gov. (2023). Pasireotide Clinical Trials Database.
4. EvaluatePharma. (2023). “Top strategies in neuroendocrine tumor therapies.”
5. FDA & EMA documentation. (2022–2023). Regulatory updates and approvals.

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This analysis aims to assist industry professionals, investors, and healthcare stakeholders in strategic decision-making regarding Signifor Lar.