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Toxicology transformed: Why accuracy now leads the way

Drug Target Review

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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New drug triggers rapid cell death in cancer models

Broad Institute

Importantly, unlike other MCL1 inhibitors that have raised concerns about cardiovascular side effects in early-stage clinical trials, BRD-810 acts quickly within cancer cells and is eliminated from the body in animal models within a few hours. This rapid clearance minimizes the drug’s potential impact on healthy cells. Nature Cancer.

Drugs 133
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Elacestrant 

New Drug Approvals

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. 1] Its plasma protein binding exceeds 99% and remains independent of concentration. [1]

FDA 62
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Orforglipron’

New Drug Approvals

then was licensed to Lilly in 2018. [1] 1] [3] Clinical trials The results of Phase I safety and Phase II ascending-dose clinical trials enrolling people with obesity or type 2 diabetes were published in 2023. [4] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] April 17, 2025.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

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Gepirone

New Drug Approvals

5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 1] It is taken orally. [1] 5] SYN Synthesis Ormaza, V.

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The future of mental health treatment: Zelquistinel’s role

Drug Target Review

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD).