DA8010
/ Dong-A
- LARVOL DELTA
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June 26, 2024
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
June 26, 2024
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
January 25, 2024
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
January 25, 2024
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
January 02, 2024
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
August 24, 2023
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
August 23, 2023
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
August 22, 2023
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
August 15, 2023
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
August 14, 2023
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
May 12, 2023
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
April 13, 2023
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
February 04, 2023
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
July 07, 2022
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
April 22, 2022
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
March 16, 2022
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
August 05, 2021
[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
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