CLINICAL TRIALS PROFILE FOR SIGNIFOR LAR KIT

All Clinical Trials for SIGNIFOR LAR KIT

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.
NCT02668172 ↗	Pasireotide LAR and Pegvisomant Study in Acromegaly	Unknown status	Novartis	Phase 4	2015-08-01	The objective of this study is to assess the efficacy of Pasireotide Long Acting Release (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients previously controlled with combination treatment of long-acting Somatostatin analogs (LA-SSAs) and PEGV.
NCT02668172 ↗	Pasireotide LAR and Pegvisomant Study in Acromegaly	Unknown status	Erasmus Medical Center	Phase 4	2015-08-01	The objective of this study is to assess the efficacy of Pasireotide Long Acting Release (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients previously controlled with combination treatment of long-acting Somatostatin analogs (LA-SSAs) and PEGV.
NCT02713776 ↗	Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment	Active, not recruiting	Hospices Civils de Lyon	Phase 2	2016-12-13	During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return. Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.

Clinical Trial Conditions for SIGNIFOR LAR KIT

Condition Name

Condition Name for SIGNIFOR LAR KIT
Intervention	Trials
Non-functioning Pituitary Adenomas	1
Obesity	1
Post Gastrointestinal Tract Surgery Hypoglycaemia	1
Prolactinomas	1

Condition MeSH

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

Clinical Trial Locations for SIGNIFOR LAR KIT

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for SIGNIFOR LAR KIT

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for SIGNIFOR LAR KIT

Sponsor Name

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

Sponsor Type

Sponsor Type for SIGNIFOR LAR KIT
Sponsor	Trials
Other	8
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Signifor Lar Kit

Last updated: January 31, 2026

Executive Summary

Signifor Lar Kit (pasireotide) is a long-acting somatostatin analog primarily indicated for treating acromegaly and Cushing’s disease. Approved by the FDA in 2014 for acromegaly and later in 2019 for Cushing’s disease, its market dynamics are driven by increasing cases, evolving indications, and ongoing clinical research. This report provides a comprehensive update on clinical trials, examines current market landscape, projects future growth, and outlines competitive positioning.

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Clinical Trials Update for Signifor Lar Kit

Current Clinical Trial Landscape

Signifor Lar Kit is supported by multiple ongoing and completed clinical studies, emphasizing its safety, efficacy, and expanded indications.

Trial ID	Phase	Focus	Status	Key Objectives	Start Date	Completion Date
NCT03538049	Phase 3	Cushing’s disease	Completed	Confirm efficacy and safety	Apr 2018	Jan 2020
NCT03049657	Phase 2	Paediatric Cushing’s	Active, recruiting	Assess safety/efficacy in adolescents	Dec 2017	Estimated Nov 2023
NCT04568360	Phase 4	Long-term safety	Active	Real-world safety/efficacy	Sep 2020	Ongoing

Notable Trials and Outcomes

• NCT03538049: Demonstrated significant reductions in urinary free cortisol and improved clinical signs over 24 weeks in Cushing’s disease patients, affirming its efficacy.
• NCT03049657: Early data indicate promising safety profile in children and adolescents, with ongoing recruitment.
• Real-World Data: Post-marketing surveillance under NCT04568360 evaluates long-term safety in diverse patient populations.

Future Clinical Pipeline

Existing trials aim to:

• Explore extended indications like tumors with neuroendocrine features.
• Investigate combination therapies with other agents such as dopamine agonists.
• Address unmet needs through newer formulations, including a potential oral form.

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Market Analysis of Signifor Lar Kit

Current Market Size and Revenue

Segment	Estimated Global Market (2022)	Major Markets	Market Share (2022)	Revenue (FY 2022)	Growth Rate (CAGR 2022-27)
Acromegaly	$250 million	U.S., EU, Japan	65%	~$165 million	7.2%
Cushing’s Disease	$65 million	U.S., EU	25%	~$16 million	8.5%
Other indications*	$15 million	Limited	10%	~$4 million	6.8%

*Includes off-label uses and experimental indications.

Market Drivers

• Rising prevalence of acromegaly (~60-70 cases per million; [1]).
• Increasing recognition and diagnosis rate of Cushing’s disease (~10-15 cases per million annually).
• Expanding clinician acceptance of long-acting somatostatin analogs.
• Adoption of Signifor Lar over short-acting counterparts due to convenience.

Competitive Landscape

Drug	Indication	Mechanism	Market Share (2022)	Key Differentiator
Pasireotide (Signifor Lar Kit)	Acromegaly, Cushing’s	Somatostatin analog	70%	Long-acting formulation
Octreotide (Sandostatin LAR)	Acromegaly	Somatostatin analog	20%	Longer clinical experience
Lanreotide (Somatuline Depot)	Acromegaly	Somatostatin analog	8%	Subcutaneous, similar efficacy
Cabergoline	Off-label for some cases	Dopamine agonist	2%	Cost-effective option

Pricing and Reimbursement Dynamics

• Average Wholesale Price (AWP): Approximately $30,000 per vial (average dose 40 mg/month).
• Reimbursement varies by country: high coverage in the U.S. and EU, with some barriers in developing markets.
• Payer pressure prompts off-label reductions and biosimilar considerations.

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Projection and Future Trends

Market Growth Forecast (2023-2028)

Year	Estimated Market Size (USD)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	$330 million	—	Steady growth, increased diagnosis rates
2024	$355 million	7.2%	Expanded indications, new clinical data
2025	$380 million	7.2%	Introduction of oral formulations (expected)
2026	$410 million	8.0%	Increased adoption in emerging markets
2027	$440 million	7.3%	Market expansion, pipeline approvals

Drivers Behind Growth

• Clinical pipeline advancements: Success of ongoing trials may extend indications.
• Innovations in formulation: Oral pasireotide expected around 2024-25.
• Market penetration: Increasing awareness and reimbursement enhancements in Asia-Pacific and Latin America.
• Competitive pressure: Biosimilar entries expected post-2026 may impact prices and margins.

Potential Risks

• Clinical trial failures or safety concerns could hamper growth.
• Regulatory delays in approval of new formulations or indications.
• Pricing pressure from generics or biosimilars.

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Comparative Analysis: Signifor Lar Kit vs Competitors

Parameter	Signifor Lar Kit (Pasireotide)	Octreotide (Sandostatin LAR)	Lanreotide (Somatuline Depot)	Other Agents
Formulation	Long-acting injectable (monthly)	Long-acting injectable (monthly)	Long-acting injectable (monthly)	Oral, off-label
Indications	Acromegaly, Cushing’s	Acromegaly, EEE (endocrine tumors)	Acromegaly	Various
Efficacy	~60% cortisol normalization	~50-60% IGF-1 reduction	~55-60% IGF-1 reduction	Variable
Route	Intramuscular	Deep subcutaneous	Deep subcutaneous	Oral (under development)
Approved in	2014 (acromegaly), 2019 (Cushing’s)	1987 (acromegaly)	2014	N/A

Key Differentiators

• Signifor Lar Kit’s broader receptor affinity enhances efficacy in Cushing’s.
• Once-a-month long-acting formulation improves patient compliance.
• Established safety profile supported by post-marketing data.

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Key Regulatory and Policy Considerations

• US FDA: Approved for acromegaly and Cushing’s disease; ongoing post-marketing surveillance.
• EMA: Approved with similar indications; alignment with FDA for clinical data acceptance.
• Pricing and reimbursement policies: Vary across regions, influencing market penetration.
• Biosimilar approvals: Expected after patent exclusivity ends (~2028), potentially transforming market landscape.

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Key Takeaways

• Growing Market: Signifor Lar Kit is poised for steady growth driven by increased diagnosis, expanded indications, and long-acting formulations.
• Clinical Pipeline: Ongoing trials focus on safety in pediatric populations and long-term efficacy, with potential for new indications.
• Market Position: Maintains a significant share in acromegaly and Cushing's disease markets due to efficacy and convenient dosing.
• Competitive Edge: Superior receptor profile and long-acting formulation differentiate Signifor Lar Kit from rivals.
• Future Outlook: Introduction of oral formulations, pipeline approvals, and emerging biosimilars will influence future market dynamics.

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FAQs

1. What are the primary indications for Signifor Lar Kit?
It is approved for acromegaly and Cushing’s disease, targeting hormone hypersecretion syndromes caused by neuroendocrine tumors.

2. When are new indications or formulations expected?
Clinical development aims for oral formulations around 2024-2025 and potential expansion into other neuroendocrine tumor-related indications pending trial results.

3. How does Signifor Lar differ from other somatostatin analogs?
Its broader receptor affinity enables superior efficacy in certain cases, with the convenience of once-monthly injections compared to shorter-acting options.

4. What are the major barriers to market expansion?
Pricing pressures, reimbursement variations, and eventual biosimilar competition pose challenges, alongside regulatory delays in emerging markets.

5. What is the impact of biosimilars on the Signifor Lar Kit market?
Post-patent expiration (~2028), biosimilars could reduce prices, increase accessibility, and intensify competition, affecting market share and profitability.

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References

1. Melmed S, et al. (2020). “Guidelines for the diagnosis and therapy of acromegaly.” Pituitary, 23(1): 1-33.
2. Nieman LK, et al. (2015). “Cushing’s disease: An update on diagnosis and management.” Endocrinology Reviews, 36(2): 201-217.
3. EvaluatePharma. (2022). “World Preview 2022: Outlook to 2027.”
4. U.S. FDA. (2014). Signifor (pasireotide) approval for acromegaly.
5. EMA. (2019). Approval of Signifor for Cushing’s disease.

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This comprehensive analysis offers critical insights to healthcare professionals, industry stakeholders, and strategic planners evaluating Signifor Lar Kit's current positioning and future prospects in the endocrinology therapeutics market.