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octreotide

Trade name: sandostatin

Peptideapproved

Approved

Oct 21, 1988

Octreotide (SMS 201-995, Sandostatin) is an octapeptide that exerts pharmacologic actions similar to the natural hormone, somatostatin. It was developed by Bauer and co-authors at Sandoz. It is an even more potent inhibitor of growth hormone, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses LH response to GnRH, decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide. By virtue of these pharmacological actions, Sandostatin has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and Vasoactive Intestinal Peptide (VIP) secreting adenomas (watery diarrhea). Sandostatin substantially reduces growth hormone and/or IGF-I (somatomedin C) levels in patients with acromegaly. A radioactively labelled analogue has been used to visualize somatostatin receptors in a GRF-secreting human tumour. — NCATS

Clinical trial activity

212 trials · 200 clinical orgs · 20 marketing orgs

Phase 1
38
Phase 2
114
Phase 3
55
Phase 4
31

Earliest trial started Jan 1, 1995 (NCT00004327)

Timeline

1980s

  1. Oct 21, 1988

    Earliest FDA Approval

  2. Oct 21, 1988

    Novartis — NDA Secondary Org

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 28, 2005

    West-Ward Pharmaceutical — Marketing Organization

  2. Oct 3, 2005

    Teva — Marketing Organization

  3. Oct 3, 2005

    Eu Yan Sang — Marketing Organization

  4. Oct 3, 2005

    Meitheal — Marketing Organization

  5. Feb 10, 2006

    Fresenius — Marketing Organization

  6. Aug 14, 2007

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. Feb 10, 2011

    Mylan — Marketing Organization

  2. May 11, 2011

    Wockhardt — Marketing Organization

  3. Nov 12, 2013

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  4. Sep 7, 2018

    Heritage Pharma — Marketing Organization

  5. Sep 7, 2018

    Emcure — Marketing Organization

  6. Dec 27, 2018

    USV — Marketing Organization

2020s

  1. Jun 26, 2020

    Chiasma, Inc. — Marketing Organization

  2. Jun 26, 2020

    Amryt Research Limited — Marketing Organization

  3. Jun 26, 2020

    Amryt Research Limited — NDA Secondary Org

  4. Jun 26, 2020

    Chiesi — Marketing Organization

  5. Jun 13, 2023

    Gland Pharma Ltd — Marketing Organization

  6. Jun 13, 2023

    Fosun — Marketing Organization

  7. May 2, 2024

    Shuangcheng — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewOct 21, 1988

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H](O)[C@@H](CO)NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@H](N)CC2=CC=CC=C2)C(=O)N[C@@H](CC3=CC=CC=C3)C(=O)N[C@H](CC4=CNC5=C4C=CC=C5)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1
Mol. weight
1019.239 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • longastatin
  • ocreotide
  • octeotride
  • octeotride
  • octreotida
  • octreotida
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide
  • octreotide acetate
  • octreotide acetate
  • octreotide acetate
  • octreotide acetate
  • octreotide acetate
  • octreotide (acetate)
  • octreotide hydrochloride
  • octreotide hydrochloride
  • octreotide pamoate
  • octreotide pamoate
  • octreotidum
  • octreotidum
  • octrotide
  • octrotide
  • sandostatin
  • sandostatin
  • sandostatin
  • sandostatin
  • sandostatin
  • sandostatine
  • sandostatin lar
  • sandostatin lar
  • sms-201-995
  • sms-201-995
  • sms-201-995
  • sms 201-995 ac
  • sms 201-995 ac
  • sms-201-995 ac
  • sms-201-995 ac
  • sms 201-995 pa
  • sms pa
  • y90 resin microspheres

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06881888Phase 1Aug 31, 2026University of Alabama, Birmingham
NCT07255248N/ANov 17, 2025Harvard University
NCT07165886Phase 2/Phase 3 (Phase 3)Aug 29, 2025Shijiazhuang Pharma Group (CSPC)
NCT06878664Phase 3Jun 12, 2025Grupo Espanol de Tumores Neuroendocrinos (GETNE), Institut Gustave Roussy, Universidad Complutense de Madrid
NCT06974344Phase 4Jun 1, 2025King Faisal University
NCT06784752Phase 3May 6, 2025Novartis
NCT06558422Phase 1Dec 1, 2024Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Berkeley
NCT06592261Phase 1Sep 16, 2024Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT06505395Phase 2Jul 30, 2024Shijiazhuang Pharma Group (CSPC)
NCT06372652Phase 1Jun 18, 2024Immunwork, Inc.
NCT07057622Phase 3Dec 12, 2023—
NCT06126354Phase 1Dec 1, 2023Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yeshiva University
NCT05724134Phase 1Aug 29, 2023Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yeshiva University
NCT06085976Phase 2Aug 14, 2023Clinica Universidad de Navarra
NCT05884255Phase 3Jul 6, 2023Hengrui Therapeutics, Inc.
NCT05761431Phase 1Mar 2, 2023Capital Medical University, Shijiazhuang Pharma Group (CSPC)
NCT05459844Phase 3Jul 31, 2022People's Liberation Army of China, Sinotau Pharmaceutical Group
NCT05199038Phase 4Jun 30, 2022Tanta University
NCT05281328Phase 2/Phase 3 (Phase 3)Jun 28, 2022Camurus AB, Radboud University
NCT05364944Phase 1May 18, 2022Debiopharm
Showing 20 of 212 trials
Page 1 / 11

Organizations

Research & Development (200)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit463251999
National Cancer Institute (NCI)Government24841996
Columbia UniversityAcademic/Hospital6532006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government6121999
Camurus ABFor profit5522015
Mayo ClinicAcademic/Hospital5221998
Vanderbilt UniversityAcademic/Hospital5341996
Aspireo Pharmaceuticals LimitedFor profit4422012
Eastern Cooperative Oncology GroupAcademic/Hospital4421996
Endo PharmaceuticalsFor profit4422007
Radboud UniversityAcademic/Hospital4322010
Yeshiva UniversityAcademic/Hospital4121996
Aarhus UniversityAcademic/Hospital3232012
Ambrilia Biopharma, Inc.For profit3312007
Cedars-Sinai Medical CenterAcademic/Hospital3222007
Chiasma, Inc.For profit3312012
Grupo Espanol de Tumores Neuroendocrinos (GETNE)Academic/Hospital3322011
National Center for Research Resources (NCRR)Government3131995
National University of IrelandAcademic/Hospital3112013
Northwestern UniversityAcademic/Hospital3111999
200 organizations
Page 1 / 10

Marketing (30)

OrganizationOrg typeRelationshipDate
Amryt Research LimitedFor profitMKTGJun 26, 2020
Amryt Research LimitedFor profitNDA2Jun 26, 2020
Chiasma, Inc.For profitMKTGJun 26, 2020
ChiesiFor profitMKTGJun 26, 2020
EmcureFor profitMKTGSep 7, 2018
Eu Yan SangFor profitMKTGOct 3, 2005
FosunFor profitMKTGJun 13, 2023
FreseniusFor profitMKTGFeb 10, 2006
Gland Pharma LtdFor profitMKTGJun 13, 2023
Gland Pharma LtdFor profitSYNJun 13, 2023
Heritage PharmaFor profitSYNSep 7, 2018
Heritage PharmaFor profitMKTGSep 7, 2018
Heritage PharmaFor profitSYNSep 7, 2018
MeithealFor profitMKTGOct 3, 2005
MylanFor profitMKTGFeb 10, 2011
MylanFor profitSYNDec 12, 2025
NovartisFor profitNDA2Oct 21, 1988
Sagent Pharmaceuticals, Inc.For profitMKTGNov 12, 2013
Sagent Pharmaceuticals, Inc.For profitSYNNov 12, 2013
SandozFor profitIND—
SandozFor profitNDA—
ShuangchengFor profitMKTGMay 2, 2024
Sun PharmaceuticalsFor profitSYNJan 28, 2020
Sun PharmaceuticalsFor profitSYNJan 28, 2020
Sun PharmaceuticalsFor profitMKTGAug 14, 2007
TevaFor profitMKTGOct 3, 2005
TevaFor profitSYNDec 5, 2023
USVFor profitMKTGDec 27, 2018
West-Ward PharmaceuticalFor profitMKTGMar 28, 2005
WockhardtFor profitMKTGMay 11, 2011