News

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.

We are excited to announce the updated DDI Calculator, featuring enhancements designed to improve usability, transparency, and regulatory alignment.

What’s New in this version:

• ICH M12 Compliance by Default
  The calculator aligns with ICH M12 guideline, supporting standardized and regulatory-consistent DDI assessments.
• Administration Route Options
  Users can select between oral and parenteral routes of administration, enabling more accurate and scenario-specific predictions.
• Expanded Enzyme and Transporter Coverage
  UGTs and hepatic efflux transporters are now shown by default, with the option to include additional enzymes and transporters as needed.
• Multiple Lots per Enzyme (Induction Module)
  The induction module now supports multiple lots per enzyme, allowing for more robust and representative data inputs.
• Enhanced Parameter Guidance
  Contextual footnotes across the tool provide clearer direction for selecting parameters and using inputs correctly.
• Intermediate Values Displayed
  Greater transparency is achieved with the display of intermediate calculation values, e.g., Cmax,u, Cmat,inlet,u, helping users better understand how results are derived.

These updates are designed to make the DDI Calculator more powerful, flexible, and aligned with current scientific and regulatory expectations.

We encourage you to explore the new features and share your feedback. If you have any questions or would like a walkthrough of the updates, please don’t hesitate to reach out.

In March, we added 126 citations in DIDB, including 59 in vitro (with 19 articles published in March 2026) and 67 in vivo articles (with 37 articles published in March 2026).

3 NDAs and 1 BLA approved by the FDA in January and February 2026, including copper histidinate (ZYCUBO), difamilast (ADQUEY), milsaperidone (BYSANTI), and pegzilarginase (LOARGYS), 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.

Our team has completed data curation for all FDA drug approvals in 2025, including 34 NDAs and 12 BLAs. You can access the complete list and explore their detailed DMPK data, DDI evaluations, drug characteristics, DDI summaries, and QT assessments.

Among the small‑molecule drugs (N = 34), nearly half (N = 16) included PBPK-supported DDI assessments that informed dose recommendations in labeling. In addition, PBPK modeling was applied to two BLAs, both for ADCs, to support DDI predictions for the small‑molecule payloads in these conjugates. You can also access this subset of drugs directly on the page above by applying the PBPK filter.

In Feb, we added 97 citations in DIDB, including 51 in vitro (with 25 articles published in Feb 2026) and 46 in vivo articles (with 39 articles published in Feb 2026).

5 NDAs and 4 BLAs approved by the FDA in 2025, including aficamten (MYQORZO), elinzanetant (LYNKUET), linvoseltamab (LYNOZYFIC), narsoplimab (YARTEMLEA), pembrolizumab and berahyaluronidase alfa (KYTRUDA QLEX), penpulimab (PENPULIMAB), sevabertinib (HYRNUO), tradipitant (NEREUS), and ziftomenib (KOMZIFTI), 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 invite you to participate in our first annual customer survey. The survey takes approximately 5-10 minutes to complete. Your feedback will help us prioritize enhancements, guide new capabilities, and further strengthen the value that DIDB provides to our users.

The survey is available on the top panel of the DIDB home page, next to the search function. You may also access it directly using the following link: DIDB Customer Survey 2026

We sincerely appreciate your time and feedback, and we thank you for helping us continue to improve DIDB to better serve your needs.

In January, we added 112 citations in DIDB, including 65 in vitro (with 12 articles published in January 2026) and 47 in vivo articles (with 37 articles published in January 2026).

4 NDAs and 3 BLAs approved by the FDA in November and December 2025, including depemokimab (EXDENSUR), doxecitine and doxribtimine (KYGEVVI), etripamil (CARDAMYST), lerodalcibep (LEROCHOL), plozasiran (REDEMPLO), sibeprenlimab (VOYXACT), and zoliflodacin (NUZOLVENCE) 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 has been updated in January 2026 and is available in the Tools.

This update includes characterization of 54 compounds, encompassing substrates of CYP2D6, CYP3A, UGTs, OATP1B1, and OATP1B3 (N = 10); inhibitors of CYP1A2, CYP2C8, CYP2C9, CYP2D6, CYP3A, UGTs, P-gp, BCRP, OATP1B1, and OATP1B3 (N = 28); and inducers of CYP3A and UGTs (N = 16). One drug was identified as a strong CYP3A inhibitor and one as a strong CYP3A inducer based on dedicated DDI studies with midazolam. No sensitive substrates were identified. No drugs related to renal transporters were identified in this update.

In addition, a comprehensive review of UGT-related data curated in DIDB resulted in the characterization of 3 drugs as UGT substrates, 11 as UGT inhibitors, and 13 as UGT inducers, supported by DDI or pharmacogenetic data.

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.

In December, we added 97 citations in DIDB, including 43 in vitro (with 25 articles published in December 2025) and 54 in vivo articles (with 30 articles published in December 2025).

3 NDAs approved by the FDA in September and October 2025, including nerandomilast (JASCAYD), paltusotine (PALSONIFY), and remibrutinib (RHAPSIDO) 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.