Pasireotide Diaspartate

Treats Cushing's disease. Sold as Signifor. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Pasireotide Diaspartate (sold as Signifor), first approved Dec 14, 2012, with 1 new use approved and 0 published complete response letters.

First approved: Dec 14, 2012
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $3.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Signifor	Part D	$3.3M	+59%	21

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Pasireotide s.c. in Patients With Post-Bariatric HypoglycaemiaPost-Bariatric Hypoglycemia · RECORDATI GROUP	Phase 2	Active, not recruiting	Jul 3, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 14, 2012	SigniforNDA 200677 · New molecular entity	Recordati Rare	7	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA