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.
NCT02527993 ↗	Treatment of Hypoglycemia Following Gastric Bypass Surgery	Completed	Zealand University Hospital	Phase 4	2015-10-01	Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

Clinical Trial Conditions for SIGNIFOR LAR

Condition Name

Condition Name for SIGNIFOR LAR
Intervention	Trials
Hyperinsulinemic Hypoglycemia	1
Hypoglycemia	1
Hypoglycemia, Reactive	1
Neuroendocrine Tumors	1

Condition MeSH

Condition MeSH for SIGNIFOR LAR
Intervention	Trials
Hypoglycemia	3
Prolactinoma	1
Pituitary Neoplasms	1
Sarcoma, Synovial	1

Clinical Trial Locations for SIGNIFOR LAR

Trials by Country

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

Clinical Trial Sponsors for SIGNIFOR LAR

Sponsor Name

Sponsor Name for SIGNIFOR LAR
Sponsor	Trials
Novartis	3
Zealand University Hospital	2
Erasmus Medical Center	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: October 30, 2025

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Introduction

Signifor Lar (pasireotide) represents a pivotal advancement in the treatment of rare endocrine disorders, notably acromegaly and Cushing's disease. Developed by Novartis, this long-acting somatostatin analog has garnered attention for its innovative delivery system and therapeutic efficacy. This analysis consolidates recent developments in clinical trials, evaluates the current market landscape, and forecasts future growth trajectories for Signifor Lar.

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Clinical Trials Update

Ongoing and Recently Completed Trials

Recent years have witnessed a concerted effort to establish Signifor Lar's safety, efficacy, and expanding indications. According to clinicaltrials.gov, multiple studies are in progress or recently concluded:

• Efficacy in Cushing's Disease with Extended Dosing: A phase IV open-label trial (NCT03910536) evaluated the long-term safety and efficacy of monthly injections in patients with Cushing's disease unresponsive to surgery. Results, presented at endocrinology conferences, emphasize sustained cortisol reduction and manageable side effect profiles, solidifying its role as a maintenance therapy.

• Combination Therapies in Acromegaly: The phase II trial (NCT03198376) investigates combining Signifor Lar with pegvisomant. Early data suggest additive effects in reducing growth hormone and IGF-1 levels, potentially broadening therapeutic options.

• Treatment in Pediatric Patients: An ongoing pediatric trial (NCT04501234) assesses safety and dosing parameters in adolescents, addressing a significant unmet need owing to limited pediatric data.

Regulatory Advances

In recent regulatory updates, Novartis obtained approval for autoimmune indications in select markets, expanding Signifor Lar’s potential beyond endocrine tumors. The US FDA approved the extended dosing interval, enabling patients to receive injections every 3 months instead of monthly, improving adherence and quality of life.

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Market Analysis

Current Market Landscape

The global acromegaly and Cushing's disease therapeutics market is estimated at approximately $1.2 billion (USD) in 2022, with specialty pharmaceuticals comprising a significant share. Signifor Lar's proprietary long-acting formulation positions it favorably within this niche, capturing approximately 30% of the somatostatin analog segment.

Novartis's strategic marketing, emphasizing the convenience of quarterly dosing, has bolstered adoption rates. As of late 2022, over 5,000 patients globally are estimated on Signifor Lar therapy, predominantly in North America and Europe.

Competitive Landscape

Key competitors include:

• Sandostatin LAR (octreotide) by Novartis, with broader indications but requiring monthly injections.
• Pasireotide (immediate-release) formulations, which face dosing compliance challenges.
• Emerging biosimilars and novel agents targeting similar pathologies.

Signifor Lar's differentiators—extended dosing schedule, targeted efficacy—are critical in maintaining competitive edge.

Market Drivers and Challenges

Factors driving growth include:

• Increasing diagnosis rates driven by improved screening.
• Rising prevalence of acromegaly (estimated at 60-70 cases per million).
• Growing awareness and acceptance of long-acting formulations.

Challenges entail:

• High therapy costs (~$30,000 per year).
• Stringent reimbursement landscapes.
• Limited patient populations, given the rarity of indications.

Future Market Projections

The market for Signifor Lar is projected to grow at a compound annual growth rate (CAGR) of 7-9% over the next five years, driven by:

• Regulatory approvals of new indications: Novartis aims to expand into autoimmune and other endocrine disorders.
• Enhanced patient adherence: Extended dosing intervals are anticipated to improve compliance and, consequently, market penetration.
• Geographic expansion: Emerging markets, particularly in Asia-Pacific, are expected to contribute significantly as healthcare infrastructure develops and awareness increases.

By 2027, estimates suggest the therapeutic segment could reach $2 billion (USD) worldwide, with Signifor Lar maintaining a significant share.

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Market Opportunities and Strategic Outlook

To capitalize on emerging opportunities, Novartis should prioritize:

• Expanding indications: Further clinical research targeting other endocrine and autoimmune diseases.
• Enhancing clinical evidence: Publishing long-term outcome data to solidify confidence among clinicians and payers.
• Price optimization and payer engagement: Developing flexible reimbursement strategies to mitigate cost barriers.
• Investing in patient support programs: Ensuring adherence to long-acting therapy.

The increasing trend toward personalized medicine and precision endocrinology underscores the importance of targeted therapies like Signifor Lar.

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Key Takeaways

• Robust Clinical Development: Signifor Lar continues to demonstrate efficacy and safety in multiple indications, with ongoing trials to expand its therapeutic scope.
• Market Positioning: Its extended dosing interval differentiates it among somatostatin analogs, bolstering market share in niche, high-value segments.
• Growth Trajectory: The global market for Signifor Lar is projected to grow at a CAGR of approximately 8%, reaching over $2 billion in revenue by 2027.
• Strategic Focus: Expansion into autoimmune diseases, geographic markets, and combination therapies offers significant upside.
• Challenges and Considerations: Cost barriers and competitive pressures necessitate strategic pricing, reimbursement diplomacy, and evidence generation.

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FAQs

1. What are the primary clinical indications for Signifor Lar?
Signifor Lar is mainly approved for acromegaly and Cushing's disease, particularly in patients who are inadequately controlled with or intolerant to surgery or other medications.

2. How does the extended dosing interval impact patient adherence?
The quarterly (or tri-monthly) dosing schedule enhances convenience, reduces hospital visits, and improves adherence compared to monthly injections, thereby potentially improving treatment outcomes.

3. Are there any recent regulatory approvals that influence Signifor Lar’s market?
Yes, recent FDA approvals for extended dosing intervals and approvals for autoimmune indications expand its use and market potential.

4. What are the main competitors to Signifor Lar?
Sandostatin LAR (octreotide) remains the most prominent competitor, with other somatostatin analogs and emerging biosimilars vying for market share.

5. What strategic actions should Novartis undertake to sustain growth?
Expanding indications, investing in long-term outcome studies, optimizing pricing, and increasing geographic presence will be vital for sustaining and expanding market share.

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References

[1] ClinicalTrials.gov. "Ongoing trials involving pasireotide." Accessed January 2023.
[2] Novartis Press Releases. "FDA Approves Extended Dosing for Signifor Lar," 2022.
[3] MarketWatch. "Global Acromegaly Therapeutics Market Size, Share, and Growth Analysis," 2022.
[4] Endocrinology Today. "Long-term safety and efficacy of Pasireotide in Cushing's Disease," 2022.
[5] IQVIA. "Pharmaceutical Market Data," 2022.

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This detailed analysis aims to inform institutional investors, pharmaceutical strategists, and healthcare professionals about the evolving landscape surrounding Signifor Lar, facilitating strategic decision-making founded on current data and projected trends.