Presented at the 127th ASCPT International Meeting, March 2026
Jingjing Yu, Ichiko Petrie, Sophie Argon, Katie Owens, and Isabelle Ragueneau-Majlessi
The objective of the present work was to review recent PMRs and PMCs related to CYP3A, the enzyme most often evaluated in post-marketing studies, to characterize the nature of the requests.
Presented at the 127th ASCPT International Meeting, March 2026
Katie Owens, Jingjing Yu, Chris Kinsella, Sophie Argon, and Isabelle Ragueneau-Majlessi
A systematic evidence-based approach leveraging regulatory approved characterizations per the ICH M12 Guideline for Drug Interaction Studies and clinical DDI and/or pharmacogenetic data can be used to generate dynamic lists of potential concomitant medications for use in a particular clinical trial.
In July, we added 111 citations in DIDB, including 62 in vitro (with 13 articles published in July 2026) and 49 in vivo articles (with 36 articles published in July 2026).
3 NDAs and 1 BLA approved by the FDA from May to June in 2026, including cipeprofol (CYPSEDO), ensitrelvir (XOCOVA), sonrotoclax (BEQALZI), and veligrotug (LUMVOA) were also curated in DIDB.
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.
We’re excited to announce a new DIDB webinar series running from September to December, “Transforming Drug Interaction Evaluation Workflows with DIDB.” This series will provide practical guidance on using DIDB to efficiently access, interpret, and apply DDI evidence throughout drug development.
Across four sessions, our experts will cover:
The sessions will be presented by Dr. Ichiko Petrie and Dr. Xiaolin Xu from the Drug Interaction Solutions team, and Dr. Arne van Schanke from the Development Strategy and Evidence team. Together, they bring extensive experience in drug interactions, drug metabolism and pharmacokinetics, and DDI risk analysis.
Whether you are new to DIDB or an experienced user looking to make your DDI assessment workflow more efficient, we encourage you to join the sessions that are most relevant to your work.
Register now and reserve your spot:
Register for the DIDB Webinar Series
We look forward to seeing you there!
We are excited to share a tutorial video for the updated DDI Calculator with new features and enhancements designed to improve usability, transparency, and regulatory alignment. The video provides a step-by-step overview of how to use the current version and highlights key features to help you get the most out of the DDI Calculator.
Watch the video to learn how to use DDI Calculator Version 2.
We hope this tutorial makes it easier for you to explore and use the new capabilities of the tool. As always, we welcome your feedback and suggestions.
In June, we added 106 citations in DIDB, including 48 in vitro (with 15 articles published in June 2026) and 58 in vivo articles (with 36 articles published in June 2026).
4 drugs approved by the FDA from March to May in 2026, including icotrokinra (ICOTYDE), bulevirtide (HEPCLUDEX), pivekimab sunirine (DECNUPAZ), and vepdegestrant (VEPPANU), were also curated in DIDB.
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.
The DIDB Concomitant Meds Navigator was updated in July and is now available in the Tools section.
This update includes a comprehensive review of OAT1 and OAT3 substrate data. As a result, 61 such characteristics involving 37 compounds were added or updated. For OAT1/3 substrates with supporting clinical data showing an AUCR < 2, the potential clinical significance was further evaluated, and relevant conclusions have been included in the “Characteristic comments” column when available.
Overall, this update adds or revises 100 drug interaction characteristics involving 59 compounds. These include:
Four drugs were identified as sensitive substrates, all for CYP3A, based on clinical DDI studies or PBPK modeling and simulations using the strong CYP3A inhibitors itraconazole and ketoconazole. No compounds were identified as strong inhibitors or strong inducers in this update.
Additionally, a new “Date added” column has been introduced to the table. This feature allows you to easily filter and identify recently added or updated entries.
Visit the DIDB Concomitant Meds Navigator to explore the complete list of compounds, supporting study details, and additional pharmacokinetic information.
As always, feel free to contact us if you have any questions or comments.
In May, we added 116 citations in DIDB, including 55 in vitro (with 29 articles published in May 2026) and 61 in vivo articles (with 41 articles published in May 2026).
4 drugs approved by the FDA from Feb to April in 2026, including doravirine and islatravir (IDVYNSO), linerixibat (LYNAVOY), navepegritide (YUVIWEL), and orforglipron (FOUNDAYO), were also curated in DIDB.
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.
In March, we added 122 citations in DIDB, including 58 in vitro (with 14 articles published in April 2026) and 64 in vivo articles (with 25 articles published in April 2026).
2 drugs approved by the FDA in March 2026, including relacorilant (LIFYORLI) and tividenofusp alfa (AVLAYAH), were also curated in DIDB.
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.
The DIDB Concomitant Meds Navigator was updated in April and is now available in the Tools.
This update includes 42 drug interaction characteristics involving 22 compounds. These encompass substrates of CYP2C9, CYP3A, UGT1A9, and OATP1B1 (N = 12); inhibitors of CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1, P-gp, BCRP, OCT2, MATE1, and MATE2-k (N = 23); and inducers of CYP2C19, CYP3A, UGT1A1, and P-gp (N = 7).
Four drugs were identified as sensitive substrates, all for CYP3A, based on DDI studies with the strong CYP3A inhibitors itraconazole (N = 3) and ketoconazole (N = 1). One drug was identified as a strong CYP2D6 inhibitor and one as a strong CYP3A inducer based on dedicated DDI studies using the index substrates dextromethorphan and midazolam, respectively.
You may access the Navigator to view the full list of compounds, along with supporting study details and additional pharmacokinetic information.
As always, feel free to contact us if you have any questions or comments.