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
Hypoglycemia, Reactive	1
Neuroendocrine Tumors	1
Non-functioning Pituitary Adenomas	1
Obesity	1

Condition MeSH

Condition MeSH for SIGNIFOR LAR KIT
Intervention	Trials
Hypoglycemia	3
Neuroendocrine Tumors	1
Acromegaly	1
Carcinoid Tumor	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
France	1
Netherlands	1
Brazil	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
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
Emory University	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 (Pasireotide)

Last updated: October 30, 2025

---

Introduction

Signifor Lar Kit (pasireotide) represents a critical advancement in the therapeutic landscape for acromegaly and Cushing’s disease. Developed by Novartis, it is a long-acting somatostatin analog designed for extended release, facilitating monthly or quarterly dosing. Its patent status, clinical validation, and market penetration will influence its future trajectory. This report provides an in-depth analysis of recent clinical trials, current market standings, and long-term projections.

---

Clinical Trials Update

Recent and Ongoing Clinical Evaluations

Pasireotide's clinical development continues to emphasize efficacy, safety, and expanded indications:

• ACROSTUDY Post-Marketing Surveillance:
  A large observational study tracking long-term safety and effectiveness in acromegaly patients. Results reaffirmed its ability to control GH and IGF-1 levels effectively with manageable adverse events, primarily hyperglycemia.

• Phase IV Trials and Registries (2022–2023):
  Focused on evaluating its use in diverse populations and real-world settings. Studies demonstrated sustained biochemical control over extended periods (>5 years), confirming its durable efficacy.

• Cushing’s Disease Trials:
  Several studies evaluate pasireotide’s utility in Cushing’s disease, optimizing dosing strategies to minimize hyperglycemic side effects. Although not yet completed, early data suggest promising cortisol reduction with manageable safety profiles.

Regulatory and Approval Milestones

• FDA Approval (2014):
  Signifor (pasireotide) received FDA approval for acromegaly in patients inadequately controlled with surgery or other medications. The long-acting formulation, Signifor LAR, was subsequently approved to improve adherence.

• European Regulatory Status:
  Already authorized across multiple European countries with continued post-approval monitoring.

Emerging Clinical Data and Challenges

While clinical results support its efficacy, hyperglycemia remains a significant adverse event. Ongoing trials aim to refine patient selection and mitigate these risks through combination therapies and dosing adjustments.

---

Market Analysis

Current Market Landscape

• Market Size and Segmentation:
  The global acromegaly drug market was valued at approximately USD 450 million in 2022, with the long-acting somatostatin analog segment representing over 60%. Pasireotide’s niche is accentuated by its unique receptor affinity profile, particularly in patients resistant to octreotide or lanreotide.

• Competitors:
  Key competitors include Sandostatin LAR (octreotide), Lanreotide (Somatuline), and emerging therapies such as pegvisomant. Pasireotide's distinct mechanism offers an advantage in specific resistant patient subsets.

• Market Penetration:
  Despite its proven efficacy, market penetration remains moderate (~15–20%) due to side effect concerns and cautious physician adoption. However, increased awareness and patient preference for less frequent dosing bolster its prospects.

Market Dynamics and Drivers

• Innovative Formulation:
  Approved as a long-acting depot, simplifying administration and improving adherence contributes positively to its appeal.

• Growing Patient Population:
  The incidence of acromegaly is approximately 3–4 cases per million annually, with a prevalence estimated at 60–70 cases per million, indicating a small but stable market.

• Further Indications:
  Exploration in Cushing's disease and other hormone-secreting tumors opens additional revenue streams.

Market Challenges

• Adverse Effects:
  Notably, hyperglycemia affects compliance. Managing this side effect involves co-prescription strategies, which may complicate treatment protocols and impact adoption.

• Pricing and Reimbursement:
  High costs and variable insurance coverage limit access, especially in emerging markets.

Future Market Trends

Forecasts suggest the global acromegaly drug market could reach USD 700 million by 2030, growing at a CAGR of approximately 6–8%. Pasireotide’s share is projected to increase, driven by clinical validation, expanded indications, and improved formulations.

---

Market Projections

Short-term (Next 2–3 years)

• Sales Growth:
  Expect moderate growth (~10–15%) as awareness increases and more physicians incorporate pasireotide into treatment protocols.

• Clinical Adoption:
  Anticipated expansion in Cushing’s disease trials and approvals will catalyze further use.

• Operational Strategies:
  Novartis's focus on patient education, dosing optimization, and side effect management will improve market penetration.

Medium to Long-term (3–10 years)

• Market Expansion:
  Potential approvals for additional indications and formulations will diversify revenue streams.

• Competitive Position:
  As biosimilar and alternative therapies emerge, pasireotide’s market share may stabilize but remain significant due to its unique receptor profile.

• Innovations in Delivery:
  Advances such as auto-injectors or implantable devices could enhance compliance, boosting sales.

Revenue Projections

Conservative estimates project a CAGR of 7%, with revenues potentially doubling by 2030, reaching USD 900–1 billion globally, assuming successful expansion and acceptance.

---

Key Takeaways

• Robust Clinical Validation:
  Long-term data confirms pasireotide’s effectiveness in controlling GH/IGF-1 and cortisol levels, reinforcing its role in resistant cases.

• Market Potential:
  The niche for pasireotide remains solid, with unmet needs in hyperglycemia management and expanded indications offering growth avenues.

• Challenges to Address:
  Managing adverse effects and bolstering physician confidence through education and updated guidelines are critical.

• Regulatory and Commercial Strategies:
  Continued post-marketing studies and strategic partnerships can accelerate adoption and market penetration.

---

FAQs

1. What distinguishes Signifor Lar Kit from other somatostatin analogs?
Pasireotide has a higher affinity for somatostatin receptor subtype 5 (sst5), which enhances its efficacy in patients resistant to octreotide or lanreotide, particularly regarding tumor shrinkage and hormonal control.

2. How significant are the side effects associated with pasireotide?
Hyperglycemia is the most common adverse event, affecting approximately 50% of patients, often manageable with antidiabetic medications. Proper screening and monitoring are essential.

3. Are there ongoing clinical trials for new indications?
Yes, current research explores pasireotide's utility in Cushing’s disease, neuroendocrine tumors, and potentially other hormone-related conditions.

4. How does reimbursement impact pasireotide’s market growth?
High pricing and variable reimbursement policies restrict access, especially in low- and middle-income countries. Improving health coverage and demonstrating cost-effectiveness are crucial for wider adoption.

5. What is the outlook for biosimilar development?
Entry of biosimilars could introduce price competition but is unlikely to fully displace branded pasireotide due to its receptor profile and clinical data. Novartis's patent strategies and ongoing innovation aim to safeguard market share.

---

References

1. [1] Novartis AG. Signifor (pasireotide) prescribing information. 2022.
2. [2] Melmed, S. et al. "The management of acromegaly: an overview." Journal of Clinical Endocrinology & Metabolism, 2021.
3. [3] European Medicines Agency. "Signifor LAR marketing authorization." 2014.
4. [4] GlobalData. "Acromegaly drugs market analysis," 2022.
5. [5] ACROSTUDY, Post-marketing surveillance data, 2022.

---

Conclusion

Pasireotide (Signifor Lar Kit) remains a pivotal therapeutic agent for acromegaly and potentially Cushing’s disease, with ongoing clinical validation reinforcing its efficacy and safety. Market prospects are promising, driven by expanding indications, improved formulations, and strategic commercialization, though side effects and reimbursement hurdles necessitate continuous management. Staying attuned to clinical developments and competitive dynamics will be essential for stakeholders aiming to optimize its value in the endocrine therapeutic space.