New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0 nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Drug Target Review

SEPTEMBER 25, 2024

8 Preliminary data from the trial have shown good safety and tolerability for TT125-802, with confirmed preliminary target engagement in surrogate tissues such as hair follicles and peripheral blood mononuclear cells. 2016 Jul 1 [cited 2024 Sep 4];12(7):531–8. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. 2016 Sep 12;7(45):73486–96. 2016 May 26;57(10):1505–11. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients.

Pharmacokinetics 52

Pharmacokinetics Engineering Treatment Science 52

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Premier Consulting Blog

JANUARY 31, 2023

For example, for a combination product including one or more already-approved drugs, the WoE surrounding potential pharmacodynamic or toxicological interactions must be assessed, to determine whether the combination can be tested in clinical trials without a nonclinical toxicity study.

Small Molecule 52

Small Molecule Pharmaceuticals FDA Production 52

The Pharma Data

JUNE 28, 2021

The application is based on evidence from adequate and well-controlled studies of Xarelto in adults with additional data from two Phase III clinical trials of Xarelto in pediatric patients: EINSTEIN-Jr., From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. EINSTEIN-Jr.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM. and in Europe.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Four comments were submitted to the docket established for the 2015 Petition.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

AUGUST 16, 2024

Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting. SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017.

Science 40

Science FDA Trials Clinical Pharmacology 40

New Drug Approvals

SEPTEMBER 29, 2024

Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S.

Small Molecule 62

Small Molecule DNA Disease Trials 62

DrugBank

JUNE 18, 2025

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.

Drug Development 52

Drug Development Clinical Trials Compliance Drugs 52

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.” What’s ahead? Putting policy into practice.

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME.

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

FDA 40

FDA Science Clinical Trials Production 40

The Pharma Data

OCTOBER 6, 2021

.” In August, 2021, AstraZeneca declared high- position results from the PROVENTpre-exposure prophylaxis trial which showed AZD7442 reduced the imminence of developing discriminating COVID-19 by 77 (95 confidence interval (CI) 46, 90), compared to placebo. The trial accrued 25 cases of discriminating COVID-19 at the primary analysis.

Pharmacokinetics 52

Pharmacokinetics Trials Government Vaccine 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] 7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] 2] [3] CAS No. 23 March 2023. 64 (1): 2752.

Pharmacokinetics 62

Pharmacokinetics FDA FDA Approval Treatment 62

New Drug Approvals

APRIL 27, 2025

octane-8,1′-azolidin-1-ium]-3-yl 2-hydroxy-2,2-diphenylacetate;chloride FDA 2024, Cobenfy 9/26/2024, To treat schizophrenia Press Release Drug Trials Snapshot Trospium chloride is a muscarinic antagonist used to treat overactive bladder. [3] 9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed.

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

MAY 22, 2025

“Pharmacokinetics and Pharmacodynamics of -Lactamase Inhibitors” Pharmacotherapy. This drug is given in combination with -lactam antibiotics to inhibit -lactamase , an enzyme produced by bacteria that destroys the antibiotics. [1] 1] It was patented in 1977 and approved for medical use in 1986. [2] 24 May 2023. 39 (2): 182195.

Pharmacokinetics 62

Pharmacokinetics FDA Production FDA Approval 62