Evidence map›Paper›PMID 34783193›Full record

ArticleCPT: pharmacometrics & systems pharmacology2022

Physiologically-based pharmacokinetic modeling to predict CYP3A4-mediated drug-drug interactions of finerenone.

Thomas Wendl, Sebastian Frechen, Michael Gerisch, Roland Heinig, Thomas Eissing

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026
    Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Thomas WendlPharmaceuticals R&D, Pharmacometrics, Bayer AG, Leverkusen, Germany.ORCID 0000-0002-1153-7167
Sebastian FrechenPharmaceuticals R&D, Pharmacometrics, Bayer AG, Leverkusen, Germany.ORCID 0000-0003-1170-9392
Michael GerischPharmaceuticals R&D, Drug Metabolism and Pharmacokinetics, Bayer AG, Wuppertal, Germany.ORCID 0000-0003-3807-9036
Roland HeinigPharmaceuticals R&D, Clinical Pharmacology, Bayer AG, Wuppertal, Germany.ORCID 0000-0002-4645-5428
Thomas EissingPharmaceuticals R&D, Pharmacometrics, Bayer AG, Leverkusen, Germany.ORCID 0000-0003-4378-3423
Bayer (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Finerenone is a nonsteroidal, selective mineralocorticoid receptor antagonist that recently demonstrated its efficacy to delay chronic kidney disease (CKD) progression and reduce cardiovascular events in patients with CKD and type 2 diabetes. Here, we report the development of a physiologically-based pharmacokinetic (PBPK) model for finerenone and its application as a victim drug of cytochrome P450 3A4 (CYP3A4)-mediated drug-drug interactions (DDIs) using the open-source PBPK platform PK-Sim, which has recently been qualified for this application purpose. First, the PBPK model for finerenone was developed using physicochemical, in vitro, and clinical (including mass balance) data. Subsequently, the finerenone model was validated regarding the contribution of CYP3A4 metabolism to total clearance by comparing to observed data from dedicated clinical interaction studies with erythromycin (simulated geometric mean ratios of the area under the plasma concentration-time curve [AUCR] of 3.46 and geometric mean peak plasma concentration ratios [C

Indexed as

Cytochrome P-450 CYP3ADiabetes Mellitus, Type 2Cytochrome P-450 CYP3A InhibitorsDrug InteractionsHumansModels, BiologicalNaphthyridinesCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsfinerenoneNaphthyridines

Identifiers

PMID34783193
PMCPMC8846632
OpenAlexW3213762098

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.