DA8010 / Dong-A - LARVOL DELTA

Clinical CYP2D6-Mediated Pharmacokinetic Drug-Drug Interactions of DA-8010 with Paroxetine or Mirabegron in Healthy Korean Participants. (PubMed, Drug Des Devel Ther) - "Systemic exposure to DA-8010 increased mildly with paroxetine or mirabegron, while the pharmacokinetics of mirabegron were largely unaffected. The magnitude of interaction was within the mild range and varied according to CYP2D6 metabolic activity."

Clinical • Journal • PK/PD data • Overactive Bladder

Pharmacokinetic Drug-Drug Interactions of DA-8010 with Clarithromycin or Rifampicin: Influence of CYP2D6 Phenotype on the Extent of These Interactions. (PubMed, Drug Des Devel Ther) - "DA-8010 showed no clinically meaningful PK interaction with clarithromycin, while rifampicin significantly reduced DA-8010 exposure. Although the CYP2D6 phenotype affected overall DA-8010 exposure, it did not alter the extent of the PK interaction observed with clarithromycin or rifampicin."

Clinical • Journal • PK/PD data

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