News

2025 FDA Drug Approvals: Fully Added to DIDB

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.

Data Curation and Entry in DIDB – Feb 2026 Summary

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.

DIDB Annual Customer Survey

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.

Data Curation and Entry in DIDB – January 2026 Summary

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.

DIS Team to participate in the ASCPT 2026 Meeting, March 4-6, in Denver

Drs. Isabelle Ragueneau, Jingjing Yu, and Katie Owens will be attending the upcoming ASCPT 2026 meeting in Denver, CO. The following two posters will be presented:

Poster Title: AN EVIDENCE-BASED APPROACH FOR MANAGING DDI RISK FOR PATIENTS IN CLINICAL TRIALS

  • Presenter: Dr. Katie Owens
  • Poster Session I: Wednesday March 4, 5:00 PM-7:00 PM MT
  • Poster #: PI-111

Poster Title: UNDERSTANDING POST-MARKETING REQUIREMENTS AND COMMITMENTS FOR CYP3A-MEDIATED DRUG-DRUG INTERACTIONS: AN ANALYSIS OF FDA-APPROVED DRUGS FROM 2015 TO 2024

  • Presenter: Dr. Jingjing Yu
  • Poster Session II: Thursday March 5, 5:00 PM-7:00 PM MT
  • Poster #: PII-111

If you’re interested in exploring the new features and functionalities of the DIDB, particularly the new tool, the Concomitant Meds Navigator, please contact them (didbase@certara.com) or stop by the Certara booth to arrange a demo during the meeting.

DIDB Concomitant Meds Navigator – quarterly update

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.

Data Curation and Entry in DIDB – December Summary

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.

Data Curation and Entry in DIDB – November Summary

In November, we added 101 citations in DIDB, including 51 in vitro (with 22 articles published in November 2025) and 50 in vivo articles (with 32 articles published in November 2025).

3 NDAs approved by the FDA in August and September 2025, including elamipretide (FORZINITY), imlunestrant (INLURIYO), rilzabrutinib (WAYRILZ) 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.

Data Curation and Entry in DIDB – October Summary

In October, we added 102 citations in DIDB, including 45 in vitro (with 19 articles published in October 2025) and 57 in vivo articles (with 27 articles published in October 2025).

3 NDAs approved by the FDA in August 2025, including donidalorsen (DAWNZERA), dordaviprone (MODEYSO), and ZONGERTINIB (HERNEXEOS) 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.

Applications of PBPK for Drugs Approved by the US Food and Drug Administration in 2023 and 2024: A Review of Drug Label Clinical Trial Waivers

Presented at the 14th ISSX International Meeting, September 2025
Oliver Hatley, Olha Shuklinova, Anna Murphy, Roz Southall, Eman El-Khateeb, Jingjing Yu, Isabelle Ragueneau-Majlessi, and Iain Gardner

2025 ISSX Poster Presentation – PBPK in NDA Reviews

Abstract

The application of Physiologically Based Pharmacokinetic (PBPK) modelling in FDA NDAs was assessed across 2023 and 2024 approvals.