pasireotide

Trade name: signifor

PeptideapprovedOrphan Drug ^FDA

Approved

Dec 14, 2012

Pasireotide is a synthetic long-acting cyclic hexapeptide with somatostatin-like activity. It is marketed as a diaspartate salt called Signifor, indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (ssts). Pasireotide binds and activates the hsst receptors resulting in inhibition of ACTH secretion, which leads to decreased cortisol secretion. — NCATS

Clinical trial activity

80 trials · 53 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 2004 (NCT00088595)

Timeline

2000s

Jan 1, 2004
Novartis — Earliest Phase 2 Sponsor(trial)
Jan 1, 2006
Novartis — Earliest Phase 1 Sponsor(trial)
Jan 1, 2006
Novartis — Earliest Phase 3 Sponsor(trial)
Jul 24, 2009
Orphan Drug Designation

2010s

Dec 14, 2012
Novartis — Earliest FDA Approval
Dec 14, 2012
Recordati — Marketing Organization
Dec 14, 2012
Novartis — NDA Organization
Dec 14, 2012
Novartis — NDA Secondary Org
Dec 14, 2012
Recordati — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Bifunctional heparan sulfate N-deacetylase/N-sulfotransferase 1ACTIVATOR
NDST1 activator
- Bifunctional heparan sulfate N-deacetylase/N-sulfotransferase 1 (NDST1) ↗
Somatostatin receptor 5AGONIST
SSTR5 agonist
- Somatostatin receptor type 5 (SSTR5) ↗
Somatostatin receptor 1AGONIST
SSTR1 agonist
- Somatostatin receptor type 1 (SSTR1) ↗
Somatostatin receptor 2AGONIST
SSTR2 agonist
Non-selective but type 5 receptor is overexpressed in Cushing's disease
- Somatostatin receptor type 2 (SSTR2) ↗
Somatostatin receptor 3AGONIST
SSTR3 agonist
Non-selective but type 5 receptor is overexpressed in Cushing's disease
- Somatostatin receptor type 3 (SSTR3) ↗

Approval history

approvedDec 14, 2012

Chemistry & pharmacology

Loading structure…

SMILES

NCCCC[C@@H]1NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@@H](NC(=O)[C@@H]4C[C@H](CN4C(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H](CC6=CC=C(OCC7=CC=CC=C7)C=C6)NC1=O)OC(=O)NCCN)C8=CC=CC=C8

Mol. weight: 1047.2062 g/mol
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Topical

Sources

Also known as

cyclo((4r)-4-(2-aminoethylcarbamoyloxy)-l-prolyl-l-phenylglycyl-d-tryptophyl-l-lysyl-4-o-benzyl-l-tyrosyl-l- phenylalanyl-)
cyclo((4r)-4-(2-aminoethylcarbamoyloxy)-l-prolyl-l-phenylglycyl-d-tryptophyl-l-lysyl-4-o-benzyl-l-tyrosyl-l- phenylalanyl-)
cyclo((4r)-4-(2-aminoethylcarbamoyloxy)-l-prolyl-l-phenylglycyl-d-tryptophyl-l-lysyl-4-o-benzyl-l-tyrosyl-l-phenylalanyl-)
pasireotida
pasireotida
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasireotide
pasiréotide
pasiréotide
pasireotide diaspartate
pasireotide diaspartate
pasireotide diaspartate
pasireotide diaspartate
pasireotide disapartate
pasireotide embonate
pasireotide pamoate
pasireotide pamoate
pasireotide pamoate
pasireotide pamoate
pasireotidum
pasireotidum
signifor
signifor
signifor
signifor
som230
som230
som230
som230
som230
som 230
som 230
som 230
som 230
som-230

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07312643	Phase 1	Dec 1, 2025	Nuvisan Pharma Services, Recordati
NCT06643130	Phase 3	Nov 30, 2024	JW Pharmaceutical
NCT06295952	Phase 2	Feb 27, 2024	Memorial Sloan-Kettering Cancer Center, Recordati
NCT05928390	Phase 2	Oct 31, 2023	Recordati
NCT04826432	Phase 2	Sep 3, 2020	Institut Gustave Roussy
NCT03847207	Phase 1	Feb 13, 2019	Heptares Therapeutics Limited, Quotient
NCT03514576	Phase 4	Jun 1, 2018	University of Copenhagen
NCT03053284	Phase 2	Apr 1, 2017	Novartis, Yeshiva University
NCT03103009	Phase 1	Mar 22, 2017	Novartis, University of Colorado, Denver
NCT02749227	Phase 2	Jan 1, 2017	Columbia University
NCT02619617	Phase 2	Oct 31, 2016	Novartis
NCT02835131	N/A	Jul 13, 2016	Yeshiva University
NCT02775227	Phase 4	May 1, 2016	University of Helsinki
NCT02713776	Phase 2	Apr 1, 2016	University of Lyon
NCT02779257	Phase 4	Apr 1, 2016	Novartis, University of Maryland
NCT02780882	Phase 2	Dec 1, 2015	Cedars-Sinai Medical Center, Novartis
NCT02527993	Phase 4	Oct 1, 2015	Koege University, University of Copenhagen
NCT02668172	Phase 4	Aug 1, 2015	Erasmus University Rotterdam, Novartis
NCT02354508	Phase 3	Mar 31, 2015	Novartis
NCT02215070	Phase 2	Feb 1, 2015	Duke University

Showing 20 of 80 trials

Page 1 / 4

Organizations

Research & Development (53)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Novartis	For profit	51	31	5	2004
Cornell University	Academic/Hospital	3	2	2	2009
Recordati	For profit	3	2	2	2023
University of South Florida	Academic/Hospital	3	3	2	2011
Cedars-Sinai Medical Center	Academic/Hospital	2	1	1	2009
Duke University	Academic/Hospital	2	1	1	2009
Emory University	Academic/Hospital	2	2	2	2010
Harvard University	Academic/Hospital	2	2	2	2008
New York University	Academic/Hospital	2	2	2	2007
University of Copenhagen	Academic/Hospital	2	2	1	2015
Yeshiva University	Academic/Hospital	2	2	2	2016
Alliance Pour La Recherche en Cancerologie	Academic/Hospital	1	1	1	2010
Columbia University	Academic/Hospital	1	1	1	2017
Crolll Gmbh	For profit	1	0	1	2012
Department of Defense	Government	1	0	1	2007
Department of Veteran Affairs	Government	1	1	1	2011
Erasmus University Rotterdam	Academic/Hospital	1	1	1	2015
Federal University of Rio de Janeiro	Academic/Hospital	1	1	1	2010
Heptares Therapeutics Limited	For profit	1	1	1	2019
Hospital Avicenne	Academic/Hospital	1	1	1	2012

53 organizations

Page 1 / 3

Marketing (5)

Organization	Org type	Relationship	Date
Novartis	For profit	NDA	Dec 14, 2012
Novartis	For profit	NDA2	Dec 14, 2012
Novartis	For profit	SYN	Dec 15, 2014
Recordati	For profit	MKTG	Dec 14, 2012
Recordati	For profit	NDA2	Dec 14, 2012