somatostatin analogue

Octreotide updates

Answer

27 changes for Octreotide in the last 12 months. Latest: 2026-09-11.

DateTypeWhat changedSource
2026-09-11TrialNew trial registered: A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patients With AcromegalTrial register ClinicalTrials.gov
2026-08-24Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2026-08-20ResultsResults posted: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With AcromegalyTrial register ClinicalTrials.gov
2026-07-22LabelFDA label revised: Sandostatin (NDA019667)Regulator FDA drug label register
2026-06-23TrialNew trial registered: A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on PharmacokinTrial register ClinicalTrials.gov
2026-06-03TrialNew trial registered: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With AcromegalyTrial register ClinicalTrials.gov
2026-06-01ResultsResults posted: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLDTrial register ClinicalTrials.gov
2026-05-13RecallFDA recall, Class II: Teva Pharmaceuticals USA, Inc. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug AdministratRegulator FDA enforcement reports
2026-05-13TrialNew trial registered: An Observational Study of Octreotide Subcutaneous Depot in Patients With AcromegalyTrial register ClinicalTrials.gov
2026-04-28ResultsResults posted: Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine CarcinomasTrial register ClinicalTrials.gov
2026-04-08TrialNew trial registered: Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort StudyTrial register ClinicalTrials.gov
2026-04-06ResultsResults posted: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET PatientsTrial register ClinicalTrials.gov
2026-04-01RecallFDA recall, Class II: Teva Pharmaceuticals USA, Inc. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug AdministratRegulator FDA enforcement reports
2026-04-01RecallFDA recall, Class II: Teva Pharmaceuticals USA, Inc. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug AdministratRegulator FDA enforcement reports
2026-04-01RecallFDA recall, Class II: Teva Pharmaceuticals USA, Inc. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug AdministratRegulator FDA enforcement reports
2026-03-18TrialNew trial registered: Octreotide Microspheres for Preventing Pancreatic FistulaTrial register ClinicalTrials.gov
2026-03-10TrialNew trial registered: Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal SyndromeTrial register ClinicalTrials.gov
2026-02-27Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2026-02-04TrialNew trial registered: Effect of Insulin Lowering on LipogenesisTrial register ClinicalTrials.gov
2026-01-30LabelFDA label revised: Octreotide Acetate (ANDA216839)Regulator FDA drug label register
2026-01-21LabelFDA label revised: OCTREOTIDE ACETATE (ANDA216589)Regulator FDA drug label register
2026-01-21ResultsResults posted: Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical CarcinomasTrial register ClinicalTrials.gov
2025-12-22LabelFDA label revised: Sandostatin LAR Depot (NDA021008)Regulator FDA drug label register
2025-12-04TrialNew trial registered: Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, OctreTrial register ClinicalTrials.gov
2025-11-28TrialNew trial registered: Hoffa's Fat Pad Impingement (HFPI)Trial register ClinicalTrials.gov
2025-11-20ResultsResults posted: Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal VaricesTrial register ClinicalTrials.gov
2025-10-31ResultsResults posted: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid SyndromeTrial register ClinicalTrials.gov
2025-09-10TrialNew trial registered: Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic NeuroendocTrial register ClinicalTrials.gov
2025-08-29TrialNew trial registered: Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and PheochrTrial register ClinicalTrials.gov
2025-08-05TrialNew trial registered: [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery DiseaseTrial register ClinicalTrials.gov
2025-08-03TrialNew trial registered: 18F-AlF-NOTA-Octreotide PET in Neuroendocrine NeoplasmsTrial register ClinicalTrials.gov
2025-07-24LabelFDA label revised: Mycapssa (NDA208232)Regulator FDA drug label register
2025-07-24LabelFDA label revised: Mycapssa (NDA208232)Regulator FDA drug label register
2025-07-10TrialNew trial registered: A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETsTrial register ClinicalTrials.gov
2025-07-09TrialNew trial registered: Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine RegimenTrial register ClinicalTrials.gov
2025-06-25LabelFDA label revised: OCTREOTIDE ACETATE (ANDA217860)Regulator FDA drug label register
2025-05-15TrialNew trial registered: Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)Trial register ClinicalTrials.gov
2025-05-09ResultsResults posted: A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus LanreotideTrial register ClinicalTrials.gov
2025-04-09TrialNew trial registered: A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin AnalogsTrial register ClinicalTrials.gov
2025-03-18TrialNew trial registered: Intranasal Delivery of Octreotide for Treatment of Diabetic Macular EdemaTrial register ClinicalTrials.gov
2025-03-17ResultsResults posted: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)Trial register ClinicalTrials.gov
2025-03-17TrialNew trial registered: Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine TumorsTrial register ClinicalTrials.gov
2025-03-10TrialNew trial registered: Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical CarcinomasTrial register ClinicalTrials.gov
2025-03-04TrialNew trial registered: Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic PatientsTrial register ClinicalTrials.gov
2025-02-21LabelFDA label revised: BYNFEZIA Pen (NDA213224)Regulator FDA drug label register
2025-01-20TrialNew trial registered: Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NETTrial register ClinicalTrials.gov
2025-01-16LabelFDA label revised: Octreotide Acetate (ANDA075957)Regulator FDA drug label register
2024-12-31TrialNew trial registered: Polydeoxyribonucleotide for Elbow Lateral EpicondylitisTrial register ClinicalTrials.gov
2024-12-03LabelFDA label revised: OCTREOTIDE ACETATE (ANDA203765)Regulator FDA drug label register
2024-10-10ResultsResults posted: Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NETTrial register ClinicalTrials.gov
2024-09-19TrialNew trial registered: Graded Insulin Suppression Test P&FTrial register ClinicalTrials.gov
2024-08-16TrialNew trial registered: Human Models of Selective Insulin Resistance: Pancreatic ClampTrial register ClinicalTrials.gov
2024-07-30LabelFDA label revised: Octreotide Acetate (ANDA210317)Regulator FDA drug label register
2024-07-29LabelFDA label revised: Octreotide Acetate (ANDA216839)Regulator FDA drug label register
2024-07-25LabelFDA label revised: Octreotide Acetate (ANDA216807)Regulator FDA drug label register
2024-07-24ResultsResults posted: Effects of Sandostatin LAR® in AcromegalyTrial register ClinicalTrials.gov
2024-07-17TrialNew trial registered: A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine TuTrial register ClinicalTrials.gov
2024-07-15LabelFDA label revised: Octreotide Acetate (ANDA079198)Regulator FDA drug label register
2024-05-23LabelFDA label revised: Octreotide (ANDA077457)Regulator FDA drug label register
2024-05-22TrialNew trial registered: Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positiTrial register ClinicalTrials.gov
2024-05-07LabelFDA label revised: Octreotide (ANDA077457)Regulator FDA drug label register
2024-03-14TrialNew trial registered: 177Lu-DOTATATE for Recurrent MeningiomaTrial register ClinicalTrials.gov
2024-03-14TrialNew trial registered: Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine TumoursTrial register ClinicalTrials.gov
2024-03-08TrialNew trial registered: A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine TumorsTrial register ClinicalTrials.gov
2024-03-05ResultsResults posted: A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid TumorsTrial register ClinicalTrials.gov
2024-03-01LabelFDA label revised: Octreotide Acetate (ANDA076313)Regulator FDA drug label register
2024-02-12TrialNew trial registered: Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy VolunteersTrial register ClinicalTrials.gov
2024-02-02TrialNew trial registered: Direct Versus Indirect Effect of Amino Acids on HepatokinesTrial register ClinicalTrials.gov
2024-01-05TrialNew trial registered: Outcome of ADPKD With Octreotide LARTrial register ClinicalTrials.gov
2023-11-13TrialNew trial registered: Dexamethasone/Pancreatic Clamp P&FTrial register ClinicalTrials.gov
2023-10-17TrialNew trial registered: Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.Trial register ClinicalTrials.gov
2023-10-12TrialNew trial registered: Real-world Study on Adjuvant Octreotide Therapy in pNETsTrial register ClinicalTrials.gov
2023-10-02TrialNew trial registered: Role of Octreotide in Non Variceal BleedingTrial register ClinicalTrials.gov
2023-09-13TrialNew trial registered: "Receptor Radionuclide Therapy With 177Lu-DOTATOCTrial register ClinicalTrials.gov
2023-06-01TrialNew trial registered: An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.Trial register ClinicalTrials.gov
2023-05-30TrialNew trial registered: Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, SoTrial register ClinicalTrials.gov
2023-04-26TrialNew trial registered: Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2Trial register ClinicalTrials.gov
2023-03-09TrialNew trial registered: A Single-dose Study of Octreotide Injection in Healthy Adult SubjectsTrial register ClinicalTrials.gov
2023-03-06TrialNew trial registered: Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.Trial register ClinicalTrials.gov
2023-03-01TrialNew trial registered: Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR ExpressionTrial register ClinicalTrials.gov
2023-02-13TrialNew trial registered: Pancreatic Clamp in NAFLDTrial register ClinicalTrials.gov
2023-02-09ResultsResults posted: Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)Trial register ClinicalTrials.gov
2023-01-13TrialNew trial registered: Octreotide Improves Human Lymphatic Fluid Transport a Translational TrialTrial register ClinicalTrials.gov
2023-01-12TrialNew trial registered: The Effect of Octreotide on Wound Drainage After MastectomyTrial register ClinicalTrials.gov
2023-01-05TrialNew trial registered: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtientsTrial register ClinicalTrials.gov
2023-01-04ResultsResults posted: Acromegaly Combination Treatment StudyTrial register ClinicalTrials.gov
2022-11-29ResultsResults posted: Palliative Management of Inoperable Malignant Bowel ObstructionTrial register ClinicalTrials.gov
2022-11-16RecallFDA recall, Class I: Viatris Inc. Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.Regulator FDA enforcement reports
2022-07-28TrialNew trial registered: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA TherapyTrial register ClinicalTrials.gov
2022-07-15TrialNew trial registered: A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETsTrial register ClinicalTrials.gov
2022-05-26ResultsResults posted: Trial Using Octreotide to Enhance Liver Recovery After HepatectomyTrial register ClinicalTrials.gov
2022-05-13ResultsResults posted: Effect of Hyperglycemia on Microvascular Perfusion in Healthy AdultsTrial register ClinicalTrials.gov
2022-05-04TrialNew trial registered: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning GastTrial register ClinicalTrials.gov
2022-04-27TrialNew trial registered: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid SyndromeTrial register ClinicalTrials.gov
2022-04-27TrialNew trial registered: Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)Trial register ClinicalTrials.gov
2022-04-22ResultsResults posted: Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in AcromegalyTrial register ClinicalTrials.gov
2022-04-22TrialNew trial registered: Effect of Octreotide on SalivaTrial register ClinicalTrials.gov
2022-04-21TrialNew trial registered: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.Trial register ClinicalTrials.gov
2022-03-16TrialNew trial registered: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLDTrial register ClinicalTrials.gov
2022-01-20TrialNew trial registered: Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled STrial register ClinicalTrials.gov

The 100 newest of 432 are listed.

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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