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Once-daily sustained-release pregabalin (YHD1119) achieves quality of life outcomes comparable to twice-daily immediate-release pregabalin in patients with peripheral neuropathic pain

In a phase 3 randomized, double-blind, active-controlled trial, 296 Korean patients with peripheral neuropathic pain received either once-daily sustained-release pregabalin (YHD1119) or twice-daily immediate-release pregabalin for 12 weeks. Quality of life measures (SF-12, WSIS, PGIC, CGIC) showed no statistically significant differences between groups, with SF-12 Physical Component Summary changes of +2.50 vs +3.08 (p=0.5243) and WSIS improvements of -2.12 vs -2.19 (p=0.3691). The results support the new SR formulation as a practical alternative with comparable patient-reported benefit and once-daily dosing convenience.

Last updated: Aug 23, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score48/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Quality of life outcomes with a new sustained‑release pregabalin in a phase 3 trial of peripheral neuropathic pain.

observational

Lee S, An T, Kim S · Current medical research and opinion (2026)

Participants: N/A
Duration: 12 weeks
Intervention: Once-daily sustained-release pregabalin (YHD1119) compared to twice-daily immediate-release pregabalin
Outcome: Health-related quality of life (SF-12 physical and mental component summaries), sleep interference (Weekly Sleep Interference Scale), patient and clinician global impression of change (PGIC, CGIC)
Effect Size: N/A (no significant between-group differences; p-values ranged from 0.0880 to 0.5243)
Population: Korean adults with peripheral neuropathic pain due to diabetic peripheral neuropathy or postherpetic neuralgia

Result:

PubMed: 42622433DOI: 10.1080/03007995.2026.2719074

Mechanism Graph

Sustained-release formulation uses gastroretentive technology to prolong drug release
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Allows once-daily dosing versus twice-daily immediate-release
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Maintains steady pregabalin exposure over 24 hours
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Results in comparable quality of life and sleep outcomes to immediate-release

Limitations

  • ⚠Per-protocol analysis only, not intention-to-treat, may introduce selection bias
  • ⚠Study conducted in Korean population, limiting generalizability to other ethnic groups
  • ⚠No placebo control group, so absolute efficacy cannot be assessed
  • ⚠Duration limited to 12 weeks, long-term outcomes not evaluated

Frequently Asked Questions

What is YHD1119?▼

YHD1119 is a new sustained-release formulation of pregabalin developed using gastroretentive technology to allow once-daily dosing, compared to the standard immediate-release pregabalin taken twice daily.

How does once-daily SR pregabalin compare to IR pregabalin in quality of life?▼

In this phase 3 trial, once-daily SR pregabalin showed comparable improvements in quality of life measures (SF-12, WSIS, PGIC, CGIC) to twice-daily IR pregabalin, with no statistically significant differences between groups.

What was the sample size and duration of this study?▼

The study included 296 participants in the per-protocol analysis and lasted 12 weeks.

Is once-daily SR pregabalin a viable alternative to IR pregabalin?▼

Yes, the findings suggest that once-daily SR pregabalin provides similar patient-reported benefits and sleep improvements, offering the convenience of once-daily dosing, which may improve adherence.

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References

  1. 1.Lee S, An T, Kim S. "Quality of life outcomes with a new sustained‑release pregabalin in a phase 3 trial of peripheral neuropathic pain.." Current medical research and opinion, 2026. PMID: 42622433 DOI: 10.1080/03007995.2026.2719074
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.