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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

PubMedJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2026-05-24

Vertebral fractures in a young woman: the impact of hypogonadism, glucocorticoids and chronic disease.

Herath Madhuni M, Nguyen Hanh H HH, Milat Frances F, Ebeling Peter R PR

A premenopausal woman was reviewed for painful vertebral fractures in the context of prednisolone exposure for her newly diagnosed systemic lupus erythematosus. Known clinical risk factors for bone loss included exposure to depot medroxyprogesterone acetate for 12 yr, cigarette smoking, a family history of osteoporosis and ongoing inflammatory arthritis. Initial investigations also identified vitamin D deficiency and low bone mass for age and sex. She was treated with vitamin D and her contraception was changed to a levonorgestrel intrauterine device. In the context of further vertebral fractures confirmed with both MRI and bone scan and having had additional secondary causes of low bone mass excluded, she commenced targeted osteoporosis treatment. We discuss the complexities of managing bone fragility in young adults and the impact of depot medroxyprogesterone acetate, inflammatory disease (systemic lupus erythematosus) and glucocorticoid-induced osteoporosis on younger adults. In this woman, antiresorptive therapy with zoledronic acid was recommended; we also explore the existing evidence-base for antiresorptive and anabolic therapies in younger adults, with a particular focus on glucocorticoid-induced osteoporosis.

PMID 42176199
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PubMedThe American journal of case reports2026-05-24

Isolated Unilateral Oculomotor Neuropathy Following A Presumed Infection Treated With Corticosteroids in a Child.

Almalki Fuad F

BACKGROUND Oculomotor neuropathy represents a very small proportion of cranial nerve palsies in children. It may result from both congenital and acquired causes. Acquired causes include vasculopathies, inflammation, infections, and neoplasms. However, only a limited number of studies in adults and children have identified post-infectious isolated oculomotor neuropathy, and even fewer have investigated the therapeutic role of corticosteroids in its treatment. CASE REPORT A previously healthy 4-year-old Saudi boy presented to the emergency department with acute onset of substantial drooping of the left upper eyelid, diplopia, and subjective low-grade fever. There were no symptoms of increased intracranial pressure and no history of head trauma. Physical examination revealed complete left-sided oculomotor neuropathy and anisocoria, without involvement of other cranial nerves or additional focal findings. Neuroimaging (computed tomography, contrast-enhanced magnetic resonance imaging, magnetic resonance angiography, and magnetic resonance venography), cerebrospinal fluid analysis, and opening pressure assessment showed normal results. Other serological findings were unremarkable. No underlying etiology was identified, and a post-infectious immune-mediated process was suspected. Oral prednisolone was initiated at a dose of 2 mg/kg/day for 5 days, followed by a 5-day taper. Follow-up at 3 months demonstrated complete resolution. CONCLUSIONS This case of isolated unilateral oculomotor neuropathy after presumed infection demonstrated complete clinical recovery after a short course of oral corticosteroids. Although a causal relationship cannot be established, such treatment may be cautiously considered in children who present with acute oculomotor neuropathy and a possible post-infectious process after an extensive, inconclusive workup. Further studies are needed to confirm this observation.

PMID 42176297
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PubMedThe Journal of dermatology2026-05-23

Real-World Experience With Single Ultra-Low Dose Rituximab for Remission Induction in Pemphigus.

Jeng Yu-Chen YC, Liu Wei-Ting WT, Hsu Chao-Kai CK, Yang Chao-Chun CC

Standard-dose rituximab (SDRTX) is the established treatment for pemphigus, but optimization of cost-effectiveness and safety remains desirable. We retrospectively evaluated the efficacy of a single ultra-low dose RTX infusion (ULRTX; 100 or 200 mg) for remission induction in 12 patients with mild-to-severe pemphigus (median baseline Pemphigus Disease Area Index [PDAI] 29.5). 9 patients (75%) achieved complete remission on minimal therapy (CRMT), and among them 5 (41.7%) subsequently achieved complete remission off therapy (CROT), with a median time to CRMT and CROT of 24 weeks and 61 weeks, respectively. Significant corticosteroid sparing was achieved; 9 of 10 evaluable patients tapered prednisolone to ≤ 5 mg/day within 6 months. Despite the reduced dose of RTX, an overall decline in serum anti-desmoglein 1 and 3 IgG titers and effective peripheral B-cell depletion (≤ 1%) occurred in evaluable patients. However, early B-cell repopulation was observed in one patient who experienced an early relapse. Compared with the standard-dose group (n = 8), the ULRTX group demonstrated a favorable safety profile with significantly fewer drug-related adverse events (0% vs. 37.5%, p = 0.049), while maintaining effective clinical remission. Single-dose ULRTX appears to be a cost-efficient and biologically effective induction strategy, supporting a personalized, immunologically guided, on-demand treatment approach.

PMID 42175554
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PubMedRheumatology international2026-05-23

Still's disease in pregnancy complicated by anakinra-related hepatotoxicity and rescued by intravenous immunoglobulin: a case-based review.

Adeleye Emmanuel E, Abushama Sara S, Jeyakumar Ajanthan A, Dubey Shirish S et al.

Still's disease (SD) in pregnancy is a rare autoinflammatory disorder presenting considerable diagnostic and therapeutic challenges. Balancing maternal disease control with foetal safety is essential, and evidence supporting biologic therapies - particularly interleukin-1 (IL-1) blockade - during gestation remains scarce. A 34-year-old primigravida developed de novo SD at 27 weeks' gestation with high-grade fever, evanescent maculopapular rash, polyarthralgia, neutrophilic leucocytosis, and hyperferritinaemia (peak 27,967 ng/mL; CRP 342 mg/L; WCC 18.1 × 10⁹/L; ALT 69 IU/L). Intravenous methylprednisolone, oral prednisolone, and subcutaneous anakinra (100 mg daily) achieved disease control, but anakinra was complicated by suspected drug-induced liver injury (ALT 1138 IU/L) with biochemical improvement after withdrawal. Intravenous immunoglobulin (IVIg; 0.4 g/kg/day for 5 days) was administered as rescue therapy. Caesarean delivery at 34 weeks resulted in a healthy neonate. Postpartum control was achieved with tocilizumab, which the patient self-discontinued after two years, remaining in drug-free remission. A CABARET-compliant search of PubMed/MEDLINE, EMBASE and DOAJ (to May 2026) identified 23 publications describing 29 pregnancies; only five referenced anakinra with two cases of new antenatal exposure with no complications, underscoring the paucity of evidence for IL-1 blockade in pregnancy. SD in pregnancy demands prompt multidisciplinary assessment, exclusion of mimics (Haemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS), Haemolysis, Elevated Liver Enzymes, Low Platelets Syndrome (HELLP), sepsis, intrahepatic cholestasis of pregnancy), and vigilant monitoring for treatment-related toxicity. This case documents suspected anakinra-related hepatotoxicity and supports IVIg as a potential rescue option, with tocilizumab as a viable postpartum strategy.

PMID 42174300
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PubMedScandinavian journal of rheumatology2026-05-22

Avacopan in a compassionate use programme for severe anti-neutrophil cytoplasmic antibody-associated vasculitis in Sweden.

Gunnarsson I I, Lindholm A A, Petkovic M M, Brolin S S et al.

Avacopan (AVAC), an oral selective C5a receptor inhibitor, has been approved for treatment in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Outside randomized controlled studies, real-world data are scarce. The aim of this study was to provide further insight into the clinical experience of AVAC. We analysed data from 16 patients with severe AAV included in an AVAC compassionate use programme. Disease activity was estimated with the Birmingham Vasculitis Activity Score (BVAS). Fatigue was assessed using the Multidimensional Assessment of Fatigue (MAF). Thirteen patients (81%) were diagnosed with granulomatosis with polyangiitis (GPA) and three (19%) with microscopic polyangiitis. The mean age at AVAC initiation was 51 (range 16-74) years. The median [interquartile range (IQR)] BVAS score was 10 (3.25-13.25) at baseline and 0 (0-0) at 6 months (p < 0.0001). All but one reached clinical remission. Prednisolone was tapered from a median (IQR) dose of 25 (20-60) to 2.5 (0-5) mg/day at 6 months (p = 0.0001). Eight patients discontinued prednisolone [median time 2.5 month1 week to 10 months)]. The median (IQR) estimated glomerular filtration rate in patients with renal AAV (n = 10) increased from 50 (13-75) to 58 (15.5-88) mL/min/1.73 m2 at 6 months (p = 0.055). One patient progressed to end-stage kidney disease, while another was able to discontinue haemodialysis. Serious adverse events were seen in five of the 16 patients (31.3%). The MAF score decreased, with a mean difference of 6.65 (p = 0.05) at 6 months. The use of AVAC in a case series with mainly GPA patients led to rapid clinical improvement, reduction of corticosteroid doses, and improvement in fatigue. The findings demonstrate beneficial effects of AVAC as add-on therapy in severe AAV.

PMID 42170701
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PubMedJournal of medical case reports2026-05-22

Single Rhupus syndrome in a young man complicated by class IV lupus nephritis and pleural effusion: complete remission with cyclosporine-based therapy: a case report.

Fallouh Nawwar N, Aldakak Mohammad Alaa MA, Al Jabban Yousef Y, Ahmad Raneem R et al.

Rhupus syndrome, the coexistence of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), is an uncommon overlap disorder. Severe SLE-type organ involvement-particularly class IV lupus nephritis and clinically significant serositis-has been reported less frequently than in isolated SLE, and optimal immunosuppressive strategies in patients with concurrent renal and hematologic disease remain poorly defined. We describe a 28-year-old Arab man who presented with fatigue, weakness, knee effusion, and laboratory evidence of autoimmune hemolytic anemia with leukopenia and thrombocytopenia. Serologic evaluation revealed antinuclear antibodies, anti-double-stranded DNA antibodies, hypocomplementemia (low C3/C4), positive rheumatoid factor, and anti-cyclic citrullinated peptide antibodies, supporting an RA-SLE overlap. Urinalysis demonstrated proteinuria and microscopic hematuria, and kidney biopsy confirmed ISN/RPS class IV-G (A/C) diffuse lupus nephritis with full-house immunofluorescence. The patient initially improved on oral prednisolone, hydroxychloroquine, and mycophenolate mofetil but subsequently re-presented with orthopnea, severe fatigue, and fever. Imaging showed a large unilateral pleural effusion; pleural fluid was repeatedly exudative with negative microbiologic studies, and thoracoscopic biopsies demonstrated nonspecific chronic pleuritis, consistent with lupus pleuritis. Treatment was escalated with intravenous methylprednisolone pulses and intensified oral corticosteroids, although background therapy was continued. Cyclosporine was added primarily to address immune cytopenias in the setting of bone-marrow hypocellularity (approximately 20-40%) with preserved trilineage maturation and no evidence of abnormal or monoclonal proliferation. Clinical, hematologic, and renal remission was observed following treatment escalation, although causality cannot be inferred from a single case. This case illustrates that Rhupus syndrome may present with aggressive SLE-type organ involvement, including class IV lupus nephritis, pleural effusion, and immune cytopenias. In this patient, remission was observed after treatment escalation with a cyclosporine-based regimen; however, this should be interpreted as an observed association rather than evidence of causality or generalizable efficacy. Cyclosporine may represent a feasible immunomodulatory option in selected high-risk patients, provided careful monitoring for toxicity, particularly in the setting of lupus nephritis.

PMID 42169141
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