TheraRadar
Data updated: May 26, 2026

UCERIS (budesonide)

Corticosteroid Hormone Receptor Agonists
Immunology Approved 2013-01-14

UCERIS rectal foam is a corticosteroid indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

Source: FDA Label • SALIX • Corticosteroid
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How UCERIS Works

Budesonide is a glucocorticosteroid with high local anti-inflammatory activity. It works by binding to glucocorticoid receptors, which results in the modulation of gene transcription to inhibit the production of pro-inflammatory cytokines and mediators, thereby reducing inflammation in the rectal and sigmoid colon.

Source: FDA Label
2
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-01-14
Patent Cliff
2031

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL, RECTAL
Dosage Forms
TABLET, EXTENDED RELEASE, AEROSOL, FOAM

Companies

SALIX
Active Ingredient: BUDESONIDE

UCERIS Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2013 to 2024
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Jul 2021 SUPPL
Label · Labeling
Apr 2020 SUPPL
Label · Labeling
FDA Letter Label

What UCERIS Treats

1 indications

UCERIS is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ulcerative Colitis
Source: FDA Label

UCERIS Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

STARJEMZA
BIO-THERA SOLUTIONS
2025 4 indic.
YESINTEK
BIOCON BIOLOGICS
2024 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to UCERIS

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ABRILADA
ADALIMUMAB-AFZB
1 shared
Pfizer
Shared indications:
Ulcerative Colitis
AMJEVITA
ADALIMUMAB-ATTO
1 shared
Amgen
Shared indications:
Ulcerative Colitis
APRISO
MESALAMINE
1 shared
SALIX
Shared indications:
Ulcerative Colitis
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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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Trial Timeline

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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.

UCERIS FDA Label Details

Indications & Usage

FDA Label (PDF)

UCERIS is indicated for the treatment of Ulcerative Colitis.

View full patent landscape →
5 OB patents · 2 families · 22 international docs across 1 countries

UCERIS Patents & Exclusivity

Latest Patent: Sep 2031

Patents (5 active)

US9192581 Expires Sep 7, 2031
US8895064 Expires Sep 7, 2031
US10660858 Expires Sep 7, 2031
US10307375 Expires Sep 7, 2031
US9132093 Expires Sep 7, 2031
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for UCERIS

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 5 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Related Intelligence

Ulcerative Colitis Drug Landscape 2026 →

Data Sources

FDA Approval: NDA203634 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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