News

Data Curation and Entry in DIDB – December Summary

In December, we added 94 citations in DIDB, including 50 in vitro (with 22 articles published in December 2022) and 44 in vivo articles (with 37 articles published in December 2022).

Three recently approved NDAs and BLAs were also added: mirvetuximab soravtansine (ELAHERE), olutasidenib (REZLIDHIA), sodium phenylbutyrate and taurursodiol (RELYVRIO) 

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

DDI Marker Studies Knowledgebase – quarterly update

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated in January 2023, and is available in the DIDB Resource Center.

We continue to expand the Knowledgebase by adding more transporter data. In this update, 18 compounds were identified as substates/inhibitors/inducers of CYP enzymes and transporters (P-gp, BCRP, and OATP1B1/3). Among them, 2 compounds could lead to strong drug interactions.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g. dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics.

As always, feel free to contact us if you have any questions or comments.

Video Tutorials – Increased Visibility

Did you know that we have recorded 10 training videos so far, which are all available in the DIDB Resource Center?

In order to best benefit the DIDB users, the videos are now also accessible on the DIDB pages that are relevant to their content. For example, on the Drug Query page you have access to 3 related videos, on the QT Interval page to 1 related video …

Please note that you must be signed-in to access.

Feel free to suggest additional topics for training videos that you will find useful. Please contact us. Thank you.

Data Curation and Entry in DIDB – November Summary

In November, we added 119 citations in DIDB, including 61 in vitro (with 24 articles published in November 2022) and 58 in vivo articles (with 34 articles published in November 2022).

Three recently approved NDAs and BLAs were also added: futibatinib (LYTGOBI), teclistamab (TECVAYLI), tremelimumab (IMJUDO).

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

Data Curation and Entry in DIDB – October Summary

In October, we added 134 citations in DIDB, including 51 in vitro (with 29 articles published in October 2022) and 83 in vivo articles (with 40 articles published in October 2022).

Five recently approved NDAs and BLAs were also added: daxibotulinumtoxina (DAXXIFY), deucravacitinib (SOTYKTU), eflapegrastim (ROLVEDON), omidenepag isopropyl (OMLONTI), and terlipressin (TERLIVAZ).

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

Data Curation and Entry in DIDB – September Summary

In September, we added 137 citations in DIDB, including 70 in vitro (with 36 articles published in September 2022) and 67 in vivo articles (with 40 articles published in September 2022).

Two recently approved BLAs were also added: olipudase alfa (XENPOZYME), spesolimab (SPEVIGO).

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

DDI Marker Studies Knowledgebase – quarterly update

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated in October 2022, and is available in the DIDB Resource Center.

We continue to expand the Knowledgebase by adding more transporter data. In this update, 42 compounds (including 13 endogenous biomarkers) were added as OATP1B/1B3 substrates based on clinical DDI data and/or pharmacogenetic findings. In addition, 16 compounds were identified as substates/inhibitors/inducers of CYP enzymes and transporters (P-gp and BCRP). Among them, 20% could lead to strong drug interactions.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g. dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics.

As always, feel free to contact us if you have any questions or comments.

Strong Pharmacokinetic Drug-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2021: Mechanisms and Clinical Implications

Clin Ther. 2022 Oct6;S0149-2918(22)00323-X

Abstract

This analysis aimed to identify all strong drug-drug interactions (DDIs) associated with drugs approved by the US Food and Drug Administration (FDA) in 2021.

Enzyme- and Transporter-Mediated Clinical Drug Interactions with Drugs by the U.S. Food and Drug Administration in 2021: What Can be Learned from New Drug applications Reviews?

Presented at the ISSX/MDO Meeting, September 2022
Jingjing Yu, Yan Wang, and Isabelle Ragueneau-Majlessi

2022 ISSX Poster Presentation – 2021 NDA Reviews

Abstract

 The mechanistic evaluation of enzyme- and transporter-based drug-drug interactions (DDIs) during drug development is critical to support management strategies in the clinic.

The objectives of the study were to review pharmacokinetic-based clinical DDI data available in the new drug application (NDA) reviews for drugs approved by the FDA in 2021, and to understand the main mechanisms that mediate interactions resulting in label recommendations.