Signifor

(Pasireotide)

ApprovedPeptide

Pasireotide is used to treat Cushing's disease (a condition caused by a pituitary tumor that produces too much cortisol hormone) and neuroendocrine tumors. It works by reducing the amount of hormones these tumors produce.[2] Signifor is currently approved and in use across 26 indications[4].[1]

Signifor is one of 352 small molecule programs targeting Merkel cell skin cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

351

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Merkel Cell Skin CancerApproved

Lung CancerApproved

ACTH Syndrome, EctopicApproved

ThymomaApproved

Kidney DiseaseApproved

Lymphoid NeoplasmApproved

Familial HyperinsulinismActive, not recruiting

Uveal MelanomaApproved

Islet Cell TumorApproved

Breast Ductal Carcinoma in SituApproved

Merkel Cell Skin CancerApproved

Approved

Lung CancerApproved

Approved

ACTH Syndrome, EctopicApproved

Approved

ThymomaApproved

Approved

Kidney DiseaseApproved

Approved

Lymphoid NeoplasmApproved

Approved

Familial HyperinsulinismPreclinical

Active, not recruiting

Uveal MelanomaApproved

Approved

Islet Cell TumorApproved

Approved

Breast Ductal Carcinoma in SituApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

306 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Signifor

RRECORDATI GROUP

Approved

33 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 5

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Secretin-Ferring

Ferring

Preclinical

1 10

Sulfonylureas

Eli Lilly

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Study completion

NCT06295952

Q4 2029

Post-ApprovalActive, not recruiting

Complication

NCT02775227

Clinical

Trials by Indication[1]

Acromegaly4 trials

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Completed· Novartis logo

Novartis·Phase 3·NCT00600886·358 enrolled

Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Completed· Novartis logo

Novartis·Phase 1·NCT00446082·85 enrolled

An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

Completed· Novartis logo

Novartis·Phase 2·NCT00171730·30 enrolled

Show 1 more trial

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Completed· Novartis logo

Novartis·Phase 3·NCT01137682·198 enrolled

Safety and Efficacy3 trials

Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Completed·RRECORDATI GROUP··NCT02310269·152 enrolled

Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease

Completed· Novartis logo

Novartis·Phase 2·NCT00171951·19 enrolled

Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00434148·162 enrolled

Prostate Cancer2 trials

Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 1/2·NCT01468532·18 enrolled

Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01313559·6 enrolled

Refractory1 trial

Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment

Completed·HHospices Civils de Lyon·Phase 2·NCT02713776·57 enrolled

Treatment Failure1 trial

Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

Completed·RRobert Benamouzig·Phase 2·NCT02622906·24 enrolled

20 more indications

Adenoma1 trial

Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

Completed·UUniversidade Federal do Rio de Janeiro·Phase 2/3·NCT01620138·21 enrolled

Statin1 trial

Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

Completed·—·Phase 2·NCT01128192·45 enrolled

Tumors1 trial

SOM230 Ectopic ACTH-producing Tumors

Withdrawn·—·Phase 2·NCT02780882

Hyperinsulinemic Hypoglycemia1 trial

Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia

Completed·UUniversity of Colorado, Denver·Phase 1·NCT03103009·1 enrolled

ESS1 trial

A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310

Completed·NNxera Pharma UK Limited·Phase 1·NCT03847207·42 enrolled

Complication1 trial

HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Active, not recruiting·HHelsinki University Central Hospital·Phase 4·NCT02775227·126 enrolled

Unresectable1 trial

Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases

Completed·EEmory University·Phase 1·NCT01469572·13 enrolled

Neuroendocrine Tumor1 trial

Pasireotide Treatment for Neuroendocrine Tumor

Withdrawn·UUniversity of Maryland, Baltimore·Phase 4·NCT02779257

Hepatocellular Carcinoma1 trial

Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT01488487·24 enrolled

Breast Cancer1 trial

Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

Completed·AAlliance Pour La Recherche en Cancerologie·Phase 2·NCT01356862·91 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00690430·186 enrolled

Pancreatectomy1 trial

Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00994110·439 enrolled

Treatment1 trial

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Completed·RRECORDATI GROUP·Phase 4·NCT01794793·337 enrolled

Toxicity1 trial

Pasireotide in Prevention of GI Toxicity

Completed·—·Phase 2·NCT02215070·37 enrolled

Hepatic Function1 trial

Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function

Completed· Novartis logo

Novartis·Phase 1·NCT00698464·34 enrolled

Dumping Syndrome1 trial

Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT01895296·9 enrolled

Hypoglycemia1 trial

Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia

No longer available·MMontefiore Medical Center··NCT02835131

Carcinoid Tumor1 trial

Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Completed· Novartis logo

Novartis·Phase 2·NCT00088595·45 enrolled

Thyroid Cancer1 trial

Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer

Completed·EEmory University·Phase 2·NCT01270321·42 enrolled

Unspecified3 trials

A Study of Pasireotide in People With Prolactinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06295952·10 enrolled

Pasireotide Therapy in Patients With Nelson's Syndrome

Terminated·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT01617733·8 enrolled

IGF-1 Inhibitor Pasireotide Lar in Combination With the m-TOR Inhibitor Everolimus

Withdrawn·MMilton S. Hershey Medical Center·Phase 2·NCT01234974

Regulatory

FDA Approval Timeline[5]

Feb 13, 2013

SIGNIFOR

NDA NDA200677

Mar 17, 2015

SIGNIFOR

NDA NDA200677

Jul 8, 2015

SIGNIFOR LAR KIT

NDA NDA203255

Mar 9, 2018

SIGNIFOR LAR KIT

NDA NDA203255

Mar 9, 2018

SIGNIFOR

NDA NDA200677

Jun 29, 2018

SIGNIFOR LAR KIT

NDA NDA203255

Jun 29, 2018

SIGNIFOR LAR KIT

NDA NDA203255

Jan 29, 2019

SIGNIFOR LAR KIT

NDA NDA203255

Jan 29, 2019

SIGNIFOR

NDA NDA200677

Apr 11, 2019

SIGNIFOR LAR KIT

NDA NDA203255

Apr 11, 2019

SIGNIFOR

NDA NDA200677

Jan 15, 2020

SIGNIFOR

NDA NDA200677

Jul 9, 2020

SIGNIFOR LAR KIT

NDA NDA203255

Jul 11, 2024

SIGNIFOR

NDA NDA200677

Jul 11, 2024

SIGNIFOR LAR KIT

NDA NDA203255

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Pasireotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Signifor drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pasireotide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pasireotide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA200677). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Signifor. U.S. Food & Drug Administration.
[7]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Somatostatin Receptor 2 Agonist; Somatostatin Receptor 3 Agonist; Somatostatin Receptor 1 Agonist; Somatostatin Receptor 5 Agonist[3]
Modality: Peptide[3]
Highest Phase: Approved[1]
Company: RRECORDATI GROUP

Patent Landscape[6]

Patent Cliff

Dec 14, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7759308Oct 25, 2026

7473761Dec 14, 2026

9351923May 23, 2028

Signifor

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2029

Trials by Indication[1]

Acromegaly4 trials

Safety and Efficacy3 trials

Prostate Cancer2 trials

Refractory1 trial

Treatment Failure1 trial

Adenoma1 trial

Statin1 trial

Tumors1 trial

Hyperinsulinemic Hypoglycemia1 trial

ESS1 trial

Complication1 trial

Unresectable1 trial

Neuroendocrine Tumor1 trial

Hepatocellular Carcinoma1 trial

Breast Cancer1 trial

Efficacy and Safety1 trial

Pancreatectomy1 trial

Treatment1 trial

Toxicity1 trial

Hepatic Function1 trial

Dumping Syndrome1 trial

Hypoglycemia1 trial

Carcinoid Tumor1 trial

Thyroid Cancer1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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