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prednisolone (Orapred ODT / Predonine)

✓ Approved

Concordia Pharmaceuticals · NR3C1 · Small Molecule

What is prednisolone?

prednisolone is a small molecule developed by Concordia Pharmaceuticals. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesOrapred ODT, Predonine
CompanyConcordia Pharmaceuticals
Drug ClassSmall Molecule
Molecular TargetNR3C1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Concordia Pharmaceuticals

Mechanism of Action

Molecular Targets

prednisolone acts on 1 molecular target:

NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

prednisolone is developed for 3 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Congenital, familial and genetic disordersDuchenne muscular dystrophy✓ Approved
Infections and infestationsBorna virus infection✓ Approved

Related Research Articles

PubMed[Rinsho ketsueki] The Japanese journal of clinical hematology2026-08-30

[Prolonged engraftment syndrome following autologous stem cell transplantation in Hodgkin lymphoma with prior immune checkpoint inhibitor therapy].

Kirito Keisuke K, Takeda Yusuke Y, Kimeda Chiharu C, Takakura Taiki T et al.

A 51-year-old woman with classical Hodgkin lymphoma refractory to multiple chemotherapy regimens, including an immune check inhibitor (ICI), was admitted to our hospital for autologous stem cell transplantation (auto-SCT). On day 7, she presented with a fever, skin rash, and elevated monocyte counts. We diagnosed engraftment syndrome (ES) and initiated corticosteroid therapy. Her symptoms resolved quickly, and we continued hydrocortisone until day 10. On day 11, she developed a fever, skin rash, and hypoxia, which we recognized as a relapse of ES. We started prednisolone at 0.5 mg/kg/day, leading to rapid symptom resolution of her symptoms, then we tapered the prednisolone on day 18. On day 19, she presented with hypotension and hypoxia, prompting us to increase the prednisolone dose to 1 mg/kg/day. Her symptoms resolved, and we gradually tapered the prednisolone dosage; she did not experience any further relapses of ES. Prior usage of ICIs has been reported to increase the risk of immune-related toxicity during allogeneic stem cell transplantation. Based on our experience, patients who have received ICIs before auto-SCT should also be closely monitored for immune-related toxicities in the early post-transplant period.

PMID 42669507
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PubMedKidney medicine2026-08-30

Granulomatous Interstitial Nephritis With Perivascular Involvement in Carbamazepine-Induced DRESS Syndrome: A Case Report.

Okubo Naoto N, Wakabayashi Hanae H, Tsuchida Tomoka T, Inoue Hiroko H et al.

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a severe hypersensitivity reaction caused by certain medications, including allopurinol, antibiotics, and antiepileptic drugs. It is characterized by a widespread rash, fever, lymphadenopathy, eosinophilia, and multiorgan dysfunction, including hepatic and renal impairment. DRESS syndrome differs from typical drug eruptions in that clinical symptoms may continue or worsen even after the causative medication has been discontinued. We report the case of a 75-year-old Japanese woman who developed DRESS syndrome after taking carbamazepine. She subsequently experienced severe acute kidney injury. Despite drug discontinuation, renal function progressively deteriorated over 2 months. Renal biopsy revealed granulomatous interstitial nephritis characterized by granulomatous lesions confined to the perivascular areas of the arcuate and interlobular arteries. Additionally, lymphangiogenesis was observed. Administration of prednisolone 0.8 mg/kg/d resulted in partial improvement in renal function; however, chronic kidney disease persisted. This patient showed perivascular granulomatous interstitial nephritis, a rare histological finding in DRESS syndrome. This finding shows that granuloma formation may involve crosstalk between persistent interstitial inflammation and lymphangiogenesis. Therefore, delayed treatment initiation may negatively affect renal outcomes, underscoring the essence of the prompt recognition and treatment of DRESS syndrome.

PMID 42668610
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PubMedBrain & development2026-08-29

Comparison of oral prednisolone and ACTH therapies in infantile epileptic spasms syndrome: using BASED and E-Chess scores.

Şeref İrem Şahan İŞ, Öztürk Zeynep Z, Özbaş Cansu C, Serdaroğlu Esra E et al.

This study aimed to compare the efficacy of adrenocorticotropic hormone (ACTH) and oral prednisolone therapies in children with infantile epileptic spasms syndrome (IESS), utilizing the Burden of Amplitudes and Epileptiform Discharges (BASED) score to assess electrographic severity and the Early Childhood Epilepsy Severity Scale (E-Chess) to evaluate clinical outcomes. This retrospective cross-sectional study included 40 children aged 1 to 16 months with IESS. Children received either ACTH (n = 23) or high-dose oral prednisolone (n = 17). Electroencephalographic severity was assessed before treatment and on day 28 post-treatment using the BASED score. Clinical epilepsy severity was evaluated at one year post-treatment using the E-Chess score. Both treatment groups showed significant reductions in BASED scores (overall cohort p < 0.001; ACTH group p < 0.001; prednisolone group p = 0.007). However, there was no statistically significant difference between the ACTH and prednisolone groups regarding post-treatment BASED or E-Chess scores. While clinical factors such as gender, age, and etiology were not associated with favorable outcomes, a lower post-treatment BASED score was significantly associated with a better clinical prognosis (p = 0.007). Notably, a higher number of pretreatment anti-seizure medications (ASMs) was a strong predictor of poor clinical outcome (OR: 5.474, 95% CI: 1.849-16.207; p = 0.002). High-dose oral prednisolone and ACTH therapies demonstrated comparable efficacy in reducing electrographic and clinical seizure burden in children with IESS. Improvement in epileptiform activity, as reflected by reductions in the BASED score, is strongly associated with better clinical outcomes. Additionally, a high pretreatment medication burden may serve as an early indicator of a refractory clinical course.

PMID 42667831
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PubMedCase reports in rheumatology2026-08-29

Childhood-Onset Takayasu Arteritis With Extensive Vascular Involvement: A Four-Decade Follow-Up Case Report.

Djumaeva Naylya N, Achundjanova Gulnara G, Djumaeva Leyla L

Childhood-onset Takayasu arteritis is rare, and data on outcomes beyond two or 3 decades are exceptionally limited. We report one of the longest documented follow-up observations of childhood-onset Takayasu arteritis, spanning more than 4 decades. The disease began at 9 years of age, and the patient was diagnosed with morphologically confirmed Type III Takayasu arteritis at the age of 16 years. She underwent renal vascular angioplasty and prosthetic reconstruction of the abdominal aorta for left renal artery occlusion associated with severe renovascular hypertension. In 2010, progression of supraaortic vascular disease required aortocarotid bypass surgery, followed six months later by left nephrectomy for persistent severe hypertension. Long-term medical management included individualized intermittent treatment with low-dose prednisolone and methotrexate. Despite extensive vascular involvement, the clinical course was characterized by gradual stabilization, progressively longer periods of clinical stability, and preservation of functional independence. Recent laboratory findings demonstrated only mild elevations in inflammatory markers, while vascular imaging showed chronic extensive arterial lesions with well-developed collateral circulation, preserved cardiac function, and preserved function of the solitary right kidney. The favorable long-term course was likely multifactorial, reflecting staged vascular reconstruction, individualized medical management, and adaptive collateral circulation. This case provides rare insight into the long-term evolution and management of severe childhood-onset Takayasu arteritis.

PMID 42666711
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PubMedJournal of feline medicine and surgery2026-08-29

EXPRESS: Efficacy and tolerability of sequential COP and doxorubicin chemotherapy protocol for treatment of high-grade lymphoma in cats.

Neiderfer Kayla K, Iwaki Yoshimi Y, Donnelly Lindsay L LL, Bryant Jennifer E JE et al.

ObjectivesThe aim of this study was to evaluate tolerability of a COP/DOX protocol, where cats received COP (vincristine, cyclophosphamide, and prednisolone) induction weekly for 6 weeks followed by doxorubicin (DOX) consolidation every three weeks for 6 doses. A secondary objective was to evaluate the efficacy of COP/DOX protocol in this cohort of cats.MethodsRecords were retrospectively reviewed for cats with high-grade lymphoma treated with the COP/DOX protocol from 2005-2024. Data collected included signalment, method of diagnosis, tumor location, staging, baseline diagnostics, drug dosages, adverse events, re-staging diagnostics and treatment response. Progression free survival (PFS) and survival time (ST) were estimated using the Kaplan-Meier method and compared across selected variables using log-rank test. ResultsTwenty-seven cats met inclusion criteria. The most common form of lymphoma was gastrointestinal in 33.3% of cats. The number of cats achieving a maximal response of clinical remission (CR) and partial remission (PR) throughout COP were 10 (37.0%) and 12 (44.4%), respectively. Of the 5 cats that had stable disease (SD) or progressive disease (PD) during COP, 1 achieved PR on doxorubicin. Four cats (14.8%) did not respond either to the COP or DOX part of the protocol. The overall response rate at 6 weeks after initiation of COP/DOX was 77.7%. PFS was 98 days (Interquartile range (IQR) 41 - 141) and MST was 154 days (IQR 102 - 546). The cats that had CR at the completion of DOX had PFS of 554.5 days and MST of 546 days. High grade adverse events included grade 3 and 4 neutropenia (n=3 for each) during COP. Lymphocyte: monocyte ratio and response at the completion of DOX were significantly associated with PFS and MST.Conclusions and relevanceWe conclude that the COP/DOX protocol was well tolerated by this population. PFS and MST were similar to previous reports. The COP/DOX protocol is an effective treatment approach for cats with lymphoma.

PMID 42665890
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PubMedRespirology case reports2026-08-28

Relapsing Polychondritis Presenting With Diffuse Tracheal Inflammation.

Imasato Daigo D, Toriyama Kazutoshi K, Kinoshita Hayato H, Takeda Yukihisa Y et al.

A 59-year-old man presented with sore throat and cough, and chest computed tomography and bronchoscopy revealed airway stenosis. Four McAdam's criteria supported the diagnosis of relapsing polychondritis. High-dose prednisolone and cyclophosphamide improved symptoms and airway lesions, highlighting the importance of early recognition and serial airway evaluation.

PMID 42662444
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