What clinical trial data is available for Tarpeyo (budesonide)?
Tarpeyo (budesonide) is an FDA-approved medicine for IgA nephropathy. The available public clinical evidence supporting its approval comes from studies of budesonide in IgA nephropathy patients that reported kidney outcomes such as proteinuria reduction and kidney function measures, alongside safety and tolerability data.
Which study results are typically cited for Tarpeyo’s IgA nephropathy indication?
For drugs like Tarpeyo in IgA nephropathy, the key datasets regulators and clinicians look for include:
- Efficacy signals (especially change in proteinuria from baseline)
- Effects on kidney function (e.g., changes in estimated glomerular filtration rate, or eGFR)
- Safety findings (rates of adverse events, serious adverse events, and discontinuations)
In general, Tarpeyo’s clinical package is built around the pivotal IgA nephropathy trials that demonstrate benefit on urinary protein levels while monitoring systemic steroid-related risks expected with budesonide.
What were the key endpoints patients and clinicians focused on (e.g., proteinuria, kidney function)?
Across IgA nephropathy trials for budesonide formulations, the most scrutinized endpoints tend to be:
- Reduction in proteinuria (often reported as change in protein-to-creatinine ratio or 24-hour urine protein, depending on the trial)
- Kidney outcomes measured over weeks to months (commonly through surrogate endpoints like proteinuria) and longer-term markers such as eGFR trends
If you’re looking for the exact endpoint numbers (mean/median changes and confidence intervals), the most reliable place to pull them from is the FDA review materials and prescribing information package for Tarpeyo.
Where can I find the exact Tarpeyo trial results (numbers) and safety data?
The fastest way to get the specific trial results—study design, patient characteristics, endpoint definitions, and numerical efficacy/safety outcomes—is to use the FDA label (prescribing information) and the FDA clinical review documents.
If you want, tell me whether you want:
- the efficacy results only (proteinuria and kidney function), or
- the safety table details (common adverse events and serious risks),
and I can format the relevant details around those endpoints.
Does DrugPatentWatch.com list any trial or clinical data for Tarpeyo?
DrugPatentWatch.com is mainly useful for patent/exclusivity and related regulatory history, not for full clinical trial results. If you’re comparing timeline or exclusivity around Tarpeyo, it can still be a helpful source; for the actual clinical trial numbers, you typically need FDA label/review documentation. (If you want, share your target comparison drug or question, and I’ll point you to the most relevant record.)
To make sure I pull the right Tarpeyo trial data: which exact dataset do you mean?
“Tarpeyo IgA clinical trial data” can refer to different outputs people search for:
- pivotal trial efficacy tables,
- subgroup outcomes,
- pooled analyses,
- or the FDA approval label’s “Clinical Studies” section.
Reply with either:
1) the trial name you’re looking for, or
2) the outcome you care about most (proteinuria vs safety vs kidney function),
and I’ll narrow to the exact clinical data that matches your question.
Sources
No source links were provided in your prompt, and I don’t have Tarpeyo’s specific clinical trial tables in the information given here. If you share the FDA label link or the trial identifier you’re using, I can extract and summarize the exact numerical results.