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Signifor

(Pasireotide Diaspartate)

Phase 2Small molecule

RRECORDATI GROUP

Signifor is one of 23 small molecule programs targeting Hypoglycemia. It is currently in Phase 2.

1

Indications

2

Total Trials

1

Active Trials

22

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HypoglycemiaActive, not recruiting

HypoglycemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

25 competitors in Hypoglycemia

#DrugCompanyPhaseTrials

NOVOLIN R

Aldactone

Avelox

Narcan

Proglycem

Symlin

Januvia

ZZydus Therapeutics Inc.

Luxiq

SSchering-Plough

Reglan

IIstituto Clinico Humanitas

Avexitide

AAmylyx Pharmaceuticals Inc.

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

Clinical

Trials by Indication[1]

CAR1 trial

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

Completed·RRECORDATI GROUP·Phase 1·NCT07312643·40 enrolled

Hypoglycemia1 trial

A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

Active, not recruiting·RRECORDATI GROUP·Phase 2·NCT05928390·93 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 14, 2012

SIGNIFOR

NDA NDA200677

Sources

References

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

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: RRECORDATI GROUP

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