Category: News

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.

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.

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.

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.

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.

In August, we added 104 citations in DIDB, including 39 in vitro (with 22 articles published in August 2022) and 65 in vivo articles (with 37 articles published in August 2022).

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 July, we added 73 citations in DIDB, including 35 in vitro (with 21 articles published in July 2022) and 38 in vivo articles (with 33 articles published in July 2022).

Two recently approved NDAs were also added: mavacamten (CAMZYOS), vutrisiran (AMVUTTRA).

Of note, all new drugs approved by the FDA from January to July this year (N = 16) have been curated in DIDB, and a DDI drug monograph for each drug was created.

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

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.

In June, we added 76 citations in DIDB, including 31 in vitro (with 12 articles published in June 2022) and 45 in vivo articles (with 31 articles published in June 2022).

Four recently approved NDAs were also added: vonoprazan and amoxicillin and clarithromycin (VOQUEZNA TRIPLE PAK), oteseconazole (VIVJOA), tapinarof (VTAMA), tirzepatide (MOUNJARO)

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 draft guideline published by the FDA on Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics is now available in DIDB Resource Center. Please note that you must be signed in to access.

This guideline provides recommendations for certain evaluations including pharmacokinetics, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development.

A dozen of oligonucleotide drugs have been approved by the FDA and are included in DIDB. You will find data for evaluations recommended by the FDA guidance, e.g., QT interval prolongation, organ impairment, metabolism and transport DDI.