TheraRadar
Data updated: May 26, 2026

ORTIKOS (budesonide)

Respiratory Approved 2019-06-13
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Discontinued
First Approved
2019-06-13
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, DELAYED RELEASE

Companies

Sun Pharma
Active Ingredient: BUDESONIDE

ORTIKOS Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2019 to 2024
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Jun 2022 SUPPL
Label · Labeling
Jun 2019 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What ORTIKOS Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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Clinical Trial Registry

84 trials
Trial Sponsor ID Phase Status Title
NCT05562466 CQMF149G2301 2021-005591-19, 2022-501899-26 Ph 3 recruiting A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
NCT05509933 15795 Ph 3 recruiting Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
NCT06596252 EOS-4 BUL-8/EEA 2024-515229-26-00, 2020-001314-37 Ph 3 recruiting Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
NCT06334575 3TR-ICS-COPD 2023-505245-13-00 Ph 4 recruiting Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
NCT06855043 2024-1479 A536757, SMPH\PEDIATRICS\NEONATO Ph 1, Ph 2 not yet recruiting Little Lungs Study
NCT04294641 results posted 200058 20-C-0058 Ph 2 completed Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
NCT05878093 results posted EFC17026 U1111-1256-9711 Ph 3 completed Dupilumab in Chinese Adult Participants With CRSwNP
NCT06841406 BuDy S64291 Ph 4 recruiting Budesonide as a Treatment for Functional Dyspepsia
NCT06719622 BETHESDa-CD ABM01 Ph 2, Ph 3 enrolling by invitation Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum
NCT06268301 results posted TAK-721-1003 Ph 1 completed A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
NCT06595121 BUNIPILOT UP-CLI-2022-001 Ph 1 completed Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)
NCT05444543 results posted STUDY20210671 Ph 4 completed Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
NCT03615742 DIGR H17-01336 Ph 4 recruiting Diesel Exhaust Induces Glucocorticoid Resistance
NCT04964414 results posted STUDY21050012 Ph 1, Ph 2 terminated Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19
NCT05931744 MKSU 50-7-8 Ph 2, Ph 3 completed The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
NCT03275415 N201705026 Ph 4 completed Intratracheal Budesonide/Surfactant Prevents BPD
NCT03034005 RECONSTRUCT 2016-003509-33 Ph 4 completed The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma
NCT05519514 BUDE1001 173-20 Ph 1 completed Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
NCT04064684 results posted HSC-MS-19-0566 KL2TR003168 Ph 2 terminated Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
NCT04163978 NOSi-CTP-02 Ph 2 completed Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
NCT05429775 SAN-0385/1828-BUD-3 Ph 1 completed In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
NCT02400476 results posted PUMA-NER-6201 2015-004374-15 Ph 2 completed An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
NCT01955980 results posted 12082.102 Ph 1, Ph 2 completed Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
NCT01946711 results posted 12082.101 Ph 1, Ph 2 completed Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
NCT03716115 TAME 011724 QM Ph 2 completed Therapeutic Approaches to Malnutrition Enteropathy
NCT01070888 results posted 08080372 Ph 4 terminated Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
NCT00762073 results posted MPI-101-01 Ph 2 completed Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
NCT01950507 130197 13-H-0197 Ph 1 terminated Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease
NCT04422275 Co-STAR PA-18-334 Ph 2 withdrawn Coronavirus Smell Therapy for Anosmia Recovery
NCT04132570 CCSURA001265 CCSURA001265, 5034003ALY4002 Ph 4 completed A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
NCT01253473 SACOPD SYMB0012 Ph 4 completed Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
NCT03519061 Budesonide SInus Irrigations 000001 Ph 2, Ph 3 withdrawn Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
NCT04494321 MCPE15003M4 Ph 1 completed A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
NCT02069847 results posted 13-009467 Ph 2 completed Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy
NCT00746486 BUC-56/PBC 2007-004040-70 Ph 3 terminated Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
NCT01100112 results posted CB-01-02/06 Ph 3 completed (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
NCT01783106 APRiCCOT Royal_Liverpool 2008-001137-99 Ph 2 completed Antibiotics and Hydroxychloroquine in Crohn's
NCT04080713 000326 Ph 1 completed Cortiment® MMX Pharmacokinetic Study
NCT02972866 RINEX32 EF148 Ph 3 withdrawn Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
NCT03315052 BILT 2017-7959 Ph 4 withdrawn Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
NCT00661973 2007-006664-29 07/H0803/239 Ph 4 withdrawn Inhaled Corticosteroids on Airway Smooth Muscle in Asthma
NCT02696850 results posted 201512063 Ph 4 completed The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
NCT01008423 results posted BUCF3002 Ph 3 completed Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
NCT01008410 results posted BUCF3001 Ph 3 completed Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
NCT01912872 MEXIC results posted CIGE025AMX02 Ph 4 terminated Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
NCT02986321 PIONEER CCD-06001AA1-01 2015-005548-32 Ph 2 completed A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
NCT02446418 results posted 116492 Ph 3 completed A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
NCT02604173 ASPECT results posted 35330 Ph 3 completed Altitude Sickness Prevention and Efficacy of Comparative Treatments
NCT03687515 TR-BIS Ph 3 completed Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
NCT03537326 WADA IMIMFTCL/DACORSIN/3 2017-004839-37 Ph 1 completed Study to Detect Oral Administration of Budesonide in Women.

Showing 50 of 84 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ORTIKOS FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 9 international docs across 5 countries

ORTIKOS Patents & Exclusivity

Latest Patent: Sep 2036

Patents (2 active)

US9707182 Expires Sep 9, 2036
US10172802 Expires Sep 9, 2036
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2036
  • • 8 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA211929 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.