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Lodotra®
Lodotra is a modified-release formulation of prednisone designed to release the corticosteroid in the early morning hours to align with the body's natural cortisol rhythm and reduce morning stiffness in rheumatoid arthritis.
Lodotra is a modified-release formulation of prednisone designed to release the corticosteroid in the early morning hours to align with the body's natural cortisol rhythm and reduce inflammation in rheumatoid arthritis. Used for Rheumatoid arthritis (moderate to severe, as adjunctive therapy).
At a glance
| Generic name | Lodotra® |
|---|---|
| Also known as | Modified Release Prednisone, Modified release prednisone, modified release tablet formulation of prednisone |
| Sponsor | Mundipharma Korea Ltd |
| Drug class | Corticosteroid (modified-release formulation) |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Lodotra uses a delayed-release technology that delivers prednisone at approximately 3 AM, matching the circadian timing of endogenous cortisol production. This chronotherapeutic approach reduces morning inflammation and stiffness in rheumatoid arthritis patients by providing anti-inflammatory corticosteroid activity when disease activity is typically highest. The timing optimization allows for lower total daily doses while improving clinical efficacy and potentially reducing systemic corticosteroid side effects.
Approved indications
- Rheumatoid arthritis (moderate to severe, as monotherapy or adjunctive therapy)
Common side effects
- Infection
- Hypertension
- Hyperglycemia
- Osteoporosis
- Insomnia
Key clinical trials
- Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis (PHASE3)
- A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (PHASE2)
- A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR (PHASE3)
- Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lodotra® CI brief — competitive landscape report
- Lodotra® updates RSS · CI watch RSS
- Mundipharma Korea Ltd portfolio CI