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Sandostatin

(Octreotide)

ApprovedPeptide

Octreotide is used to control symptoms caused by certain tumors that release hormones (like carcinoid tumors and VIPomas) and to treat abnormally high growth hormone levels in people with acromegaly.[2] Sandostatin is currently approved and in use across 47 indications[4].[1]

Sandostatin is one of 860 small molecule programs targeting Hyperinsulinemia. It is currently in Approved.

47

Indications

80

Total Trials

5

Active Trials

859

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

21

Patents

Pipeline

Status by Indication[4][1]

Indication

HyperinsulinemiaActive, not recruiting

Proliferative Diabetic RetinopathyApproved

Migraine DisorderApproved

Liver TransplantActive, not recruiting

Orthostatic IntoleranceActive, not recruiting

Prader-Willi SyndromeActive, not recruiting

Portal HypertensionActive, not recruiting

Orthostatic HypotensionActive, not recruiting

Gastric Neuroendocrine Tumor, Well Differentiated, Low or Intermediate GradeActive, not recruiting

ThymomaActive, not recruiting

HyperinsulinemiaPreclinical

Active, not recruiting

Proliferative Diabetic RetinopathyApproved

Approved

Migraine DisorderApproved

Approved

Liver TransplantApproved

Active, not recruiting

Orthostatic IntolerancePhase 1/Phase 2

Active, not recruiting

Prader-Willi SyndromePreclinical

Active, not recruiting

Portal HypertensionApproved

Active, not recruiting

Orthostatic HypotensionPhase 1

Active, not recruiting

Gastric Neuroendocrine Tumor, Well Differentiated, Low or Intermediate GradePreclinical

Active, not recruiting

ThymomaPhase 2

Active, not recruiting

Showing 10 of 43 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Sandostatin

Halaven

Tecentriq

Megace

Bristol-Myers Squibb

Blenoxane

Bristol-Myers Squibb

Lexiscan

Adenocard

Zolymbus

Sporanox

SSebela Pharmaceuticals Development LLC

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Timeline

Expected Milestones

Q4 2027

Phase 1Not yet recruiting

Diabetic Macular Edema

NCT06881888

Q3 2028

Phase 3Recruiting

GEP-NET

NCT05477576

Q4 2029

Phase 1/2Active, not recruiting

Orthostatic Intolerance

NCT00262470

Q3 2030

Post-ApprovalNot yet recruiting

Liver Transplant

NCT06974344

Clinical

Trials by Indication[1]

Acromegaly7 trials

Preoperative Octreotide Treatment of Acromegaly

Completed·SSt. Olavs Hospital·Phase 4·NCT00521300·62 enrolled

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Completed· Novartis logo

Novartis·Phase 3·NCT00600886·358 enrolled

Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

Terminated· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT01295060·12 enrolled

Show 4 more trials

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Unknown status·CChiasma, Inc.·Phase 3·NCT03252353·56 enrolled

Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

Completed·CChiasma, Inc.·Phase 3·NCT01412424·155 enrolled

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Terminated· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00765323·169 enrolled

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Completed·CChiasma, Inc.·Phase 3·NCT02685709·146 enrolled

Efficacy and Safety3 trials

Octreotide Efficacy and Safety in First-line Acromegalic Patients

Completed· Novartis logo

Novartis·Phase 4·NCT00171886·20 enrolled

Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.

Unknown status·—·Phase 2·NCT06085976·62 enrolled

Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00690430·186 enrolled

Neuroendocrine Tumors3 trials

Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

Unknown status·PPeking Union Medical College Hospital··NCT03812939·30 enrolled

AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00427349·46 enrolled

A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

Completed·MMemorial Sloan Kettering Cancer Center·Phase 4·NCT03289741·51 enrolled

Immunodeficiency2 trials

A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

Completed· Novartis logo

Novartis·N/A·NCT00002253

A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea

Completed· Novartis logo

Novartis·N/A·NCT00002252

Bleeding2 trials

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Terminated·AAdventHealth·Phase 4·NCT02032784·33 enrolled

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Completed·KKorea University·Phase 4·NCT00966355·1,034 enrolled

53 more indications

Esophageal Varices2 trials

Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

Terminated·MMedical University of South Carolina·Phase 4·NCT03624517·34 enrolled

Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

Unknown status·TTanta University·Phase 4·NCT05199038·184 enrolled

Single Dose2 trials

Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.

Completed·AAspireo Pharmaceuticals Limited·Phase 2·NCT02235987·20 enrolled

Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173

Completed·AAspireo Pharmaceuticals Limited·Phase 1·NCT02217826·8 enrolled

Obesity2 trials

Effect of Obesity-derived Cytokines on Protein Turnover and Carbohydrate Metabolism in Human Skeletal Muscle

Completed·UUniversity of Nottingham·N/A·NCT02305069·26 enrolled

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

Completed·UUniversity College Dublin·N/A·NCT02010385·30 enrolled

Acute Variceal Bleeding2 trials

RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding

Completed·TTheodor Bilharz Research Institute·N/A·NCT03061604·105 enrolled

Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT04028323·60 enrolled

Pancreatic2 trials

Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

Completed·UUniversity of Liverpool·Phase 3·NCT02457156·295 enrolled

Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Unknown status·SSaint Vincent's Hospital, Korea·N/A·NCT02920567·282 enrolled

Gastrointestinal2 trials

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

Completed·SSt. James's Hospital, Ireland·N/A·NCT02381249·40 enrolled

Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer

Completed·SSt. James's Hospital, Ireland·N/A·NCT02385617·20 enrolled

Hepatorenal Syndrome2 trials

Angiotensin 2 for Hepatorenal Syndrome

Withdrawn·UUniversity of California, Los Angeles·Phase 2·NCT04048707

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

Completed·LLahore General Hospital·N/A·NCT07460908·60 enrolled

Hypoglycemia2 trials

Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

Completed·UUniversity of Aarhus·N/A·NCT01865760·33 enrolled

Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia

Completed·AAlbert Einstein Healthcare Network·Phase 3·NCT00804297·40 enrolled

Headache1 trial

Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache

Unknown status·—·Phase 1/2·NCT00274170·56 enrolled

Orthostatic Intolerance1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Phase 1/2·NCT00262470·150 enrolled

Carcinoid Syndrome1 trial

Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Terminated· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 1/2·NCT00884715·10 enrolled

Hyperglycemia1 trial

Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

Completed·UUniversity of Virginia·Phase 1·NCT03520569·15 enrolled

Prevention1 trial

Octreotide VS Placebo in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery

Unknown status·HHadassah Medical Organization·Phase 2·NCT02437825·40 enrolled

Outcome1 trial

Outcome of ADPKD With Octreotide LAR

Active, not recruiting· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research··NCT06193616·70 enrolled

Hemodynamic1 trial

Hemodynamic Effects of Terlipressin and High Dose Octreotide

Completed·SShanghai Zhongshan Hospital·Phase 4·NCT02119884·88 enrolled

Liver Disease1 trial

Octreotide in Severe Polycystic Liver Disease

Completed·MMayo Clinic·Phase 2/3·NCT00426153·42 enrolled

Growth1 trial

The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

Completed·AAspireo Pharmaceuticals Limited·Phase 2·NCT02217800·8 enrolled

Hypothalamic Obesity1 trial

A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

Completed· Novartis logo

Novartis·Phase 4·NCT00171613·32 enrolled

Orthostatic Hypotension1 trial

Treatment of Orthostatic Hypotension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223691·389 enrolled

Portal Hypertension1 trial

Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Unknown status·JJuan A. Arnaiz·Phase 4·NCT04353193·36 enrolled

Carcinoid Tumor1 trial

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

Completed· Novartis logo

Novartis·Phase 3·NCT00412061·429 enrolled

Phase II1 trial

Phase II Study With ITF2984 in Acromegalic Patients

Completed· Italfarmaco logo

Italfarmaco·Phase 2·NCT02111044·48 enrolled

Adult1 trial

A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

Terminated· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT03571594·76 enrolled

Complication1 trial

Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Completed·MMansoura University·N/A·NCT02474914·104 enrolled

Hepatectomy1 trial

Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

Terminated·FFox Chase Cancer Center·Phase 2·NCT03179995·23 enrolled

Prader-Willi syndrome1 trial

Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)

Terminated·—·N/A·NCT00399893·5 enrolled

Postoperative Pancreatic Fistula1 trial

Prevention of Postoperative Pancreatic Fistula by Somatostatin

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03000946·655 enrolled

Hereditary Hemorrhagic Telangiectasia1 trial

Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004327·8 enrolled

Pediatric Patients1 trial

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Completed·IIndiana University·Phase 4·NCT01917773·13 enrolled

Gastrointestinal hemorrhage1 trial

Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage

Completed·GGeneral Hospital of Shenyang Military Region··NCT03846180·1,682 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 1/2·NCT00463983·25 enrolled

Anemia1 trial

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias

Completed·RRadboud University Medical Center·Phase 3·NCT02384122·62 enrolled

GEP-NET1 trial

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Recruiting·RRayzeBio, Inc.·Phase 3·NCT05477576·288 enrolled

Breast Cancer1 trial

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer

Terminated· Novartis logo

Novartis·Phase 2·NCT02294786·62 enrolled

Efficacy1 trial

The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Completed·—·Phase 4·NCT00534677·320 enrolled

Age1 trial

Palliative Management of Inoperable Malignant Bowel Obstruction

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT04027348·15 enrolled

Cervical Carcinoma1 trial

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT06865677·2 enrolled

ESS1 trial

Ghrelin Suppression by Octreotide in Prader-Willi

Unknown status·OOregon Health and Science University·N/A·NCT01613495·2 enrolled

Mechanically Ventilated Patients1 trial

Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

Completed·—·Phase 2·NCT02916433·5 enrolled

Cirrhosis1 trial

Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure

Withdrawn·AAnna Cruceta·Phase 2·NCT01587222

Thymoma1 trial

Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Completed· Novartis logo

Novartis·Phase 2·NCT00332969·25 enrolled

Lymphangioleiomyomatosis1 trial

Treatment With Octreotide in Patients With Lymphangioleiomyomatosis

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00005906·4 enrolled

Hepatocellular Carcinoma1 trial

Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Completed· Novartis logo

Novartis·Phase 3·NCT00241020·270 enrolled

Meningioma1 trial

Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas

Completed·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT02333565·20 enrolled

Liver Transplant1 trial

Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)

Not yet recruiting·KKing Faisal Specialist Hospital & Research Center·Phase 4·NCT06974344·80 enrolled

Trial1 trial

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Completed·RRigshospitalet, Denmark·Phase 1·NCT05683444·16 enrolled

Gastric Cancer1 trial

Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer

Completed·FFredrik Klevebro·Phase 2·NCT04871204·20 enrolled

Hemorrhagic Shock1 trial

Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock

Withdrawn·—·N/A·NCT03891849

Peritoneal Carcinomatosis1 trial

Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Completed· Novartis logo

Novartis·Phase 2·NCT00332696·64 enrolled

Hyperinsulinemia1 trial

Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia

Completed·—··NCT05171751·50 enrolled

Diabetic Macular Edema1 trial

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Not yet recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT06881888·60 enrolled

Mastectomy1 trial

The Effect of Octreotide on Wound Drainage After Mastectomy

Completed·IIkechukwu Bartholomew Ulasi·Phase 4·NCT05682209·41 enrolled

Unspecified3 trials

Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

Completed·AAspireo Pharmaceuticals Limited·Phase 1·NCT02217839·42 enrolled

Autologous Fibrin Glues for Fistulas Closure

Completed·JJinling Hospital, China·Phase 1·NCT01561066·122 enrolled

Effects of Glucagon Administration on Energy Expenditure

Completed·—·Phase 1·NCT02237053·6 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 21, 1988

SANDOSTATIN

NDA NDA019667

Nov 25, 1998

SANDOSTATIN LAR

NDA NDA021008

Jun 26, 2020

MYCAPSSA

NDA NDA208232

Sep 27, 2024

BYNFEZIA PEN

NDA NDA213224

Sources

References

[1]
ClinicalTrials.gov — 80 trial records for Octreotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sandostatin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Octreotide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Octreotide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213224). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sandostatin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sun Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Somatostatin Receptor Agonist[3]
Modality: Peptide[3]
Highest Phase: Approved[1]
Company: Sun Pharma

Patent Landscape[6]

Patent Cliff

Sep 17, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9566246Sep 17, 2029

8329198Sep 17, 2029

11986529Sep 17, 2029

8535695Sep 17, 2029

11969471Sep 17, 2029

16 more patents

9265812Sep 17, 2029

11052126Feb 3, 2036

11857595Feb 3, 2036

10238709Feb 3, 2036

12246054Feb 3, 2036

10695397Feb 3, 2036

12251418Feb 3, 2036

11510963Feb 3, 2036

11338011Feb 3, 2036

10342850May 15, 2038

11534553Nov 3, 2040

11246991Nov 3, 2040

11052196Nov 3, 2040

11890316Dec 28, 2040

11141457Dec 28, 2040

12350475Dec 29, 2041

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