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Signifor (PASIREOTIDE)

Recordati · FDA-approved approved Recombinant protein Quality 50/100

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 namePASIREOTIDE
SponsorRecordati
Drug classSomatostatin Analog [EPC]
TargetSomatostatin receptor type 5
ModalityRecombinant protein
Therapeutic areaOncology
PhaseFDA-approved
First approval2012

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-

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Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

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