Sandostatin LAR

ApprovedSmall molecule

Novartis

Sandostatin LAR is one of 12 small molecule programs targeting Acromegaly. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AcromegalyCompleted

Hypothalamic ObesityCompleted

AcromegalyApproved

Completed

Hypothalamic ObesityApproved

Completed

Competition

Competitive Landscape

11 competitors in Acromegaly

#DrugCompanyPhaseTrials

Sandostatin

Sun Pharma

Approved

7 2

Lanreotide Acetate

AAlbireo, an Ipsen Company

Approved

5 3

Sandostatin LAR

Novartis

Approved

4 4

Dostinex

MAR002

1 6

Genotropin

Pfizer

Preclinical

1 7

Sandostatin

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

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

Timeline

Expected Milestones

Q3 2028

Phase 2Recruiting

Pancreatic Neuroendocrine Tumor

NCT06505395

Clinical

Trials by Indication[1]

Acromegaly4 trials

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Completed· Pfizer logo

Pfizer·Phase 4·NCT00068042·100 enrolled

Effects of Sandostatin LAR® in Acromegaly

Completed·—·Phase 4·NCT01424241·21 enrolled

Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Completed·UUniversity of Aarhus·Phase 4·NCT01618513·84 enrolled

Show 1 more trial

A Randomized, Parallel-group, Multicenter Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Long-acting Octreotide Injection in Patients With Acromegaly.

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT07814651·78 enrolled

Pancreatic Neuroendocrine Tumor2 trials

A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)

Recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT06505395·90 enrolled

A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Terminated·DDebiopharm International SA·Phase 1·NCT05364944·19 enrolled

Statin2 trials

Pegvisomant And Sandostatin LAR Combination Study

Completed· Pfizer logo

Pfizer·Phase 4·NCT00068029·75 enrolled

Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®

Suspended·AAzidus Brasil·Phase 1·NCT01086982·16 enrolled

Prader-Willi syndrome1 trial

Prader-Willi Syndrome and Appetite

Terminated·UUniversity of British Columbia·Phase 3·NCT00175305·10 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01278342·70 enrolled

2 more indications

Neuroendocrine Carcinoma1 trial

Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas

Unknown status·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2/3·NCT01744249·255 enrolled

Hypothalamic Obesity1 trial

Pediatric Hypothalamic Obesity

Completed· Novartis logo

Novartis·Phase 4·NCT00076362·60 enrolled

Regulatory

FDA Approval Timeline[4]

May 17, 1999

SANDOSTATIN LAR

NDA NDA021008

Jul 13, 1999

SANDOSTATIN LAR

NDA NDA021008

Jul 2, 2001

SANDOSTATIN LAR

NDA NDA021008

Jan 3, 2002

SANDOSTATIN LAR

NDA NDA021008

May 13, 2002

SANDOSTATIN LAR

NDA NDA021008

Dec 18, 2003

SANDOSTATIN LAR

NDA NDA021008

Apr 19, 2004

SANDOSTATIN LAR

NDA NDA021008

Apr 19, 2004

SANDOSTATIN LAR

NDA NDA021008

Oct 14, 2004

SANDOSTATIN LAR

NDA NDA021008

May 10, 2006

SANDOSTATIN LAR

NDA NDA021008

May 10, 2006

SANDOSTATIN LAR

NDA NDA021008

Mar 3, 2008

SANDOSTATIN LAR

NDA NDA021008

Jan 25, 2010

SANDOSTATIN LAR

NDA NDA021008

Sep 30, 2011

SANDOSTATIN LAR

NDA NDA021008

Nov 30, 2012

SANDOSTATIN LAR

NDA NDA021008

Jan 30, 2014

SANDOSTATIN LAR

NDA NDA021008

May 19, 2014

SANDOSTATIN LAR

NDA NDA021008

Jul 17, 2014

SANDOSTATIN LAR

NDA NDA021008

Aug 21, 2014

SANDOSTATIN LAR

NDA NDA021008

May 18, 2015

SANDOSTATIN LAR

NDA NDA021008

May 20, 2016

SANDOSTATIN LAR

NDA NDA021008

Jul 22, 2016

SANDOSTATIN LAR

NDA NDA021008

Dec 21, 2018

SANDOSTATIN LAR

NDA NDA021008

Apr 11, 2019

SANDOSTATIN LAR

NDA NDA021008

Mar 30, 2021

SANDOSTATIN LAR

NDA NDA021008

Feb 9, 2023

SANDOSTATIN LAR

NDA NDA021008

Jan 5, 2024

SANDOSTATIN LAR

NDA NDA021008

Jul 11, 2024

SANDOSTATIN LAR

NDA NDA021008

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Sandostatin LAR. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sandostatin LAR compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sandostatin LAR. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021008). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Sandostatin LAR

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Acromegaly4 trials

Pancreatic Neuroendocrine Tumor2 trials

Statin2 trials

Prader-Willi syndrome1 trial

Efficacy and Safety1 trial

Neuroendocrine Carcinoma1 trial

Hypothalamic Obesity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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