pregabalin SR (YHD1119) / Yuhan Corp - LARVOL DELTA

OPTIMUM: Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P4 | N=151 | Completed | Sponsor: Yuhan Corporation | Recruiting ➔ Completed

Trial completion • Diabetic Neuropathy • Pain

Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. (PubMed, Transl Clin Pharmacol) - P1 | "Simulated steady-steady pregabalin concentrations after once-daily Y75T dosing in subjects with eGFR 45 mL/min/1.73 m were within the range of steady-state concentrations simulated after once-daily Y150T dosing in subjects with eGFR 90 mL/min/1.73 m. The total pregabalin exposure of Y75T in patients with moderate renal impairment was comparable with that of Y150T in subjects with near-normal renal function. ClinicalTrials.gov Identifier: NCT05012436."

Journal • PK/PD data • Nephrology • Renal Disease

A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain (clinicaltrials.gov) - P4 | N=130 | Completed | Sponsor: Yuhan Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain (clinicaltrials.gov) - P4 | N=130 | Active, not recruiting | Sponsor: Yuhan Corporation

New P4 trial • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Yuhan Corporation | Recruiting ➔ Completed | Trial completion date: Jan 2022 ➔ May 2022 | Trial primary completion date: Dec 2021 ➔ May 2022

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

Efficacy and Safety of a New Sustained-released Pregabalin Formulation Compared with Immediate-release Pregabalin in Patients with Peripheral Neuropathic Pain: A Randomized Non-inferiority Phase 3 Trial. (PubMed, Clin J Pain) - P3 | "The results demonstrate that the new once-daily SR pregabalin formulation is non-inferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain, and is well tolerated in Korean patients with DPN or PHN after 12 weeks of treatment. Trial registration: ClinicalTrials.gov (identifier NCT02985216)."

Clinical • Head-to-Head • Journal • P3 data • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Yuhan Corporation

Clinical • New P1 trial • Renal Disease

Pharmacokinetics of a New, Once-Daily, Sustained-Release Pregabalin Tablet in Healthy Male Volunteers. (PubMed, Clin Ther) - P1 | "The bioavailability of the pregabalin SR 300 mg formulation is increased if taken with a high-fat meal. Once-daily pregabalin SR 300 mg is bioequivalent to twice-daily pregabalin IR 150 mg under fed conditions at steady state. The pregabalin SR formulation is expected to improve patient adherence. ClinicalTrials.gov identifiers: NCT02783183 (bioequivalence study) and NCT03191136 (food effect study)."

Clinical • Journal • PK/PD data

OPTIMUM: Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P4; N=150; Recruiting; Sponsor: Yuhan Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Diabetic Neuropathy • Pain

OPTIMUM: Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P4; N=150; Not yet recruiting; Sponsor: Yuhan Corporation

New P4 trial • Diabetic Neuropathy • Pain