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.

Clinical Trial Conditions for SIGNIFOR LAR KIT

Condition Name

Condition Name for SIGNIFOR LAR KIT
Intervention	Trials
Desmoplastic Small Round Cell Tumor	1
Synovial Sarcoma	1
Enterostomy	1
Hyperinsulinemic Hypoglycemia	1

Condition MeSH

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

Clinical Trial Locations for SIGNIFOR LAR KIT

Trials by Country

Trials by Country for SIGNIFOR LAR KIT
Location	Trials
Germany	2
United States	2
Netherlands	1
Brazil	1
Denmark	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
Erasmus Medical Center	1

Sponsor Type

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

SIGNIFOR LAR KIT Market Analysis and Financial Projection

Last updated: May 5, 2026

What does the latest clinical and market picture show for SIGNIFOR LAR (pasireotide) kit?

What is SIGNIFOR LAR and what is the core commercial profile?

SIGNIFOR LAR is the long-acting injectable formulation of pasireotide, a somatostatin receptor ligand. It is marketed as SIGNIFOR LAR kit for patients with Cushing’s disease who have not had successful surgery or are not candidates for surgery, and it has an oncology-adjacent somatostatin biology profile through receptor-driven mechanisms.

Commercially, the product sits in the high-cost specialty endocrine market segment where uptake depends on:

• confirmed Cushing’s disease diagnosis workflows,
• availability of experienced care centers,
• reimbursement coverage and prior authorization,
• and prescriber familiarity with long-acting regimens.

Which indications drive the near-term demand case?

The near-term demand base for SIGNIFOR LAR is anchored in:

• Cushing’s disease (approved label indication).

No other indications are required to establish a baseline market view for SIGNIFOR LAR as a “kit” product, since the market proposition and prescribing behavior track label scope, payer coverage, and guideline adoption in Cushing’s disease.

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What is the clinical-trials update status for SIGNIFOR LAR?

No complete, source-grounded “latest update” can be produced for SIGNIFOR LAR without specific trial identifiers, study phases, and up-to-date postings from trial registries or sponsor communications. Under the constraints here, a complete and accurate clinical update (trial starts, ongoing status, readouts, and results chronology) cannot be generated.

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How is SIGNIFOR LAR positioned in the competitive landscape for Cushing’s disease?

What are the main competitor modalities and how they compete for patients?

Cushing’s disease is a niche, high-acuity market where competitors typically include:

• pituitary-directed medical therapy (other somatostatin-pathway agents, receptor-targeted drugs),
• adrenolytic and steroidogenesis inhibitors (systemic cortisol reduction),
• steroid receptor modulation approaches (when used per label/line of therapy),
• and surgical and radiotherapeutic pathways that reduce drug demand after successful disease control.

SIGNIFOR LAR’s differentiator is long-acting somatostatin receptor engagement with receptor-subtype activity consistent with clinical use in refractory or ineligible surgical populations. In practice, adoption correlates with:

• control of hypercortisolism,
• tolerability in a chronic endocrine setting,
• and payer coverage.

Where does product switching usually occur?

Switching in Cushing’s disease usually follows:

• inadequate cortisol response on current therapy,
• adverse events or lab monitoring burden,
• treatment interruptions or dose optimization issues,
• changes in availability or payer restriction.

SIGNIFOR LAR faces standard class dynamics of somatostatin-pathway therapies: prescriber selection tends to be influenced by prior treatment response and monitoring comfort.

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What market data supports a forecast, and what does the demand model look like?

Can a numeric market projection be produced from the evidence provided?

A complete projection requires external numeric inputs:

• treated-prevalence or incidence estimates for Cushing’s disease within the relevant geographies,
• diagnosis rates and line-of-therapy patterns,
• uptake curves by drug,
• pricing and reimbursement assumptions,
• competitor penetration and pipeline timing,
• and patent/launch-expiry or biosimilar/generic risk.

No such numeric inputs are present in the prompt, and a complete forecast cannot be generated under the accuracy constraint.

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What decisions can be made with non-numeric strategic projections?

What levers determine SIGNIFOR LAR’s trajectory despite missing quantitative inputs?

Even without numeric market sizing, the trajectory depends on a small set of decision levers:

1. Reimbursement and prior authorization friction

   • Specialty pharmacy workflows, payer policies, and documentation requirements determine accessible patient volumes.

2. Treatment sequencing versus competing cortisol-lowering options

   • Uptake improves when SIGNIFOR LAR is positioned as an earlier medical-line option for refractory disease rather than last-line therapy.

3. Clinical differentiation through durability and tolerability

   • In practice, long-acting therapies win when patients maintain response without destabilizing adverse-event patterns requiring discontinuation.

4. Global label execution and patient flow

   • Real-world uptake depends on specialist center capacity and adherence to monitoring and follow-up protocols.

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What is the likely outlook for SIGNIFOR LAR’s next 12 to 36 months?

What are the directional drivers that will matter most?

Directional outlook is driven by:

• ongoing absorption from existing Cushing’s disease patient cohorts already managed on medical therapy,
• incremental growth tied to new diagnoses and referrals,
• and any changes to competitive share from other endocrine therapies.

A numeric “market forecast” and “clinical trials update” cannot be responsibly stated without registry-verified trial status and validated market sizing inputs.

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Key Takeaways

• SIGNIFOR LAR (pasireotide) kit is a specialty, long-acting somatostatin-pathway therapy for Cushing’s disease, with its commercial base anchored in label-driven patient selection and reimbursement access.
• A complete clinical-trials update and a numeric market projection cannot be produced from the information provided here, because the required registry-verified trial details and quantitative market inputs are not available in the prompt.
• The product’s near-term performance is determined by payer access, sequencing versus competing cortisol-lowering options, durability/tolerability in chronic use, and specialist center patient flow.

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FAQs

1. What is SIGNIFOR LAR used for?
   It is used for Cushing’s disease in patients who have not had successful surgery or are not candidates for surgery.

2. What drug class does SIGNIFOR LAR belong to?
   It is a long-acting somatostatin receptor ligand (pasireotide).

3. What typically drives uptake of SIGNIFOR LAR in real-world settings?
   Diagnosis-to-referral pathways, payer prior authorization, and prescriber comfort with long-acting somatostatin therapy.

4. What is the main competitive pressure on SIGNIFOR LAR?
   Other Cushing’s disease medical therapies and the availability and outcomes of surgery and radiotherapy that can reduce drug-treated volumes.

5. Can you provide a 12- to 36-month market forecast here?
   Not as a numeric projection, because the prompt does not include the registry-verified clinical data and market sizing inputs required for a complete, accurate forecast.

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References (APA)

No sources were provided in the prompt, and no external, registry-specific trial or market documents were cited.