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Signifor (PASIREOTIDE)
Signifor works by binding to somatostatin receptors on the surface of cells, mimicking the natural hormone somatostatin to reduce cortisol production.
Signifor (Pasireotide) is a somatostatin analog developed by Novartis and currently owned by Recordati Rare. It targets the somatostatin receptor type 5 and is a small molecule modality. FDA-approved in 2012 for the treatment of hypercortisolism, Signifor works by mimicking the natural hormone somatostatin to reduce cortisol production. As a patented medication, it is not yet available as a generic. Key safety considerations include potential effects on blood sugar and electrolyte levels.
At a glance
| Generic name | PASIREOTIDE |
|---|---|
| Sponsor | Recordati |
| Drug class | Somatostatin Analog [EPC] |
| Target | Somatostatin receptor type 5 |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTRs). Five human somatostatin receptor subtypes are known: SSTR 1, 2, 3, 4, and 5. These receptor subtypes are expressed in different tissues under normal physiological conditions. Corticotroph tumor cells from Cushings disease patients frequently over-express SSTR5 whereas the other receptor subtypes are often not expressed or are expressed at lower levels. Pasireotide binds and activates the SSTRs resulting in inhibition of ACTH secretion, which leads to decreased cortisol secretion.The binding affinities of endogenous somatostatin and pasireotide are shown in Table 2.Table - Binding Affinities of Somatostatin (SRIF-14) and Pasireotide to the Five Human Somatostatin Receptor Subtypes (SSTR1-5)Results are the mean +- SEM of IC50 values expressed as nmol/L.CompoundSSTR1SSTR2SSTR3SSTR4SSTR5Somatostatin (SRIF-
Approved indications
- Hypercortisolism
Common side effects
- Diarrhea
- Nausea
- Hyperglycemia
- Cholelithiasis
- Headache
- Abdominal pain
- Fatigue
- Diabetes mellitus
- Injection-site reactions
- Nasopharyngitis
- Alopecia
- Glycosylated hemoglobin increased
Drug interactions
- High Risk QT Prolonging Agents
- amiodarone
- artemether
- asenapine
- cisapride
- disopyramide
- dronedarone
- droperidol
- halofantrine
- iloperidone
- levomethadyl acetate
- lopinavir
Key clinical trials
- Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET (PHASE3)
- A Study of Pasireotide in People With Prolactinoma (PHASE2)
- Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule (PHASE1)
- Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET (PHASE3)
- Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment (PHASE2)
- Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia (PHASE2)
- Effects of Pasireotide Lar Therapy on Bone Metabolism
- Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Signifor CI brief — competitive landscape report
- Signifor updates RSS · CI watch RSS
- Recordati portfolio CI