DA8010 / Dong-A - LARVOL DELTA

A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010 (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Dong-A ST Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Renal Disease

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder (clinicaltrials.gov) - P3 | N=607 | Completed | Sponsor: Dong-A ST Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Overactive Bladder

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Dong-A ST Co., Ltd. | Recruiting ➔ Completed

Trial completion

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Dong-A ST Co., Ltd. | Recruiting ➔ Completed

Trial completion

Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Velufenacin (DA-8010) is a new muscarinic receptor antagonist under development for the treatment of overactive bladder...These results suggest a modest increase of velufenacin absorption by food intake. Velufenacin was generally safe and well tolerated at the 2.5 and 5 mg doses regardless of food."

Journal • PK/PD data • Overactive Bladder

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder (clinicaltrials.gov) - P3 | N=607 | Active, not recruiting | Sponsor: Dong-A ST Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2024 ➔ Nov 2023

Enrollment closed • Trial primary completion date • Overactive Bladder

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Dong-A ST Co., Ltd.

New P1 trial

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Dong-A ST Co., Ltd.

New P1 trial

A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010 (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Dong-A ST Co., Ltd.

New P1 trial • Renal Disease

Safety, tolerability, and pharmacokinetics of single and multiple ascending Oral doses of DA-8010 in healthy subjects: First-in-human phase I study. (PubMed, Pharmacol Res Perspect) - "A high-fat meal increased systemic exposure. DA-8010 was safe, well tolerated, and well absorbed at lower doses and moderately tolerated at higher doses without any notable effects of food and sex."

Clinical • Journal • P1 data • PK/PD data • Pain

Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study. (PubMed, Int Neurourol J) - P2 | "Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial."

Clinical • Journal • P2 data • Overactive Bladder • Urinary Incontinence • Urology

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder (clinicaltrials.gov) - P3 | N=595 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Overactive Bladder

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder (clinicaltrials.gov) - P3 | N=595 | Not yet recruiting | Sponsor: Dong-A ST Co., Ltd.

New P3 trial • Overactive Bladder

[VIRTUAL] Efficacy and Safety of DA8010, a novel M3 antagonist, in Patients with Overactive Bladder: Randomized, Double-blind, Phase 2 study (AUA 2021) - "A total of 306 patients (69.93% female) were randomized to 12 weeks of treatment in 1 of 4 groups: two experimental groups (DA8010 2.5mg or 5mg), an active reference group (Solifenacin succinate 5mg), or a placebo group. Both DA8010 2.5mg and 5mg showed clinical efficacy without serious ADRs. A phase 3 study on subdivided efficacy and safety will be conducted."

Clinical • P2 data • Overactive Bladder