crisugabalin (HSK16149) / Haisco - LARVOL DELTA

Translational development of crisugabalin for neuropathic pain. (PubMed, Br J Clin Pharmacol) - "In rodent models, crisugabalin demonstrated antinociceptive efficacy with a wider separation between antinociceptive and motor-impairing doses relative to pregabalin and no clear abuse liability signals across standard paradigms. Current evidence supports crisugabalin as a class-refinement strategy with consistent short-term efficacy in DPNP and PHN and predictable clinical pharmacology. Generalizability beyond Chinese populations, longer-term outcomes and comparative effectiveness relative to established therapies remain key gaps."

Clinical • Journal • Review • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain • Renal Disease

Clinical Studies on the Efficacy and Safety of Crisugabalin and Pregabalin in Relieving Chronic Itchy Skin Diseases (EADV 2026) - No abstract available

Clinical • Dermatology • Pruritus

Efficacy and Safety of Crisugabalin for Acute Herpetic Neuralgia in a Real-World Setting: An Observational Cohort Study (EADV 2026) - No abstract available

Clinical • Observational data • Real-world • Real-world evidence • Neuralgia

High-dose crisugabalin significantly improving the pain symptoms in patients with diabetic peripheral neuropathic pain (DPNP) (EASD 2026) - P4 | "Interim data suggest significant efficacy and a favorable safety profile of high-dose Crisugabalin among Chinese patients with DPNP."

Clinical • Diabetic Neuropathy • Metabolic Disorders

Efficacy and safety of HSK16149 for postoperative pain in Chinese patients after orthopedic surgery: a phase 2 randomized clinical trial. (PubMed, Int J Surg) - "The primary outcome was the total morphine dose within the 24-hour postoperative period, including usage from the patient-controlled analgesia device and any additional remedial analgesia. The P values calculated from the Wilcoxon rank sum test comparing the four HSK16149 groups to the placebo were 0.0824, 0.0239, 0.0261, and 0.0076, respectively. HSK16149 capsules reduced postoperative opioid consumption in Chinese patients undergoing orthopedic surgery, showing that receiving 240 mg HSK16149 was recommended and appeared to be well tolerated."

Clinical • Journal • P2 data • Anesthesia • Orthopedics • Pain

Real-World Study of Crisugabalin(HSK16149) for the Treatment of Rosacea (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: The First Affiliated Hospital with Nanjing Medical University | Enrolling by invitation ➔ Completed | N=60 ➔ 30 | Trial completion date: Dec 2026 ➔ Apr 2026 | Trial primary completion date: Oct 2026 ➔ Apr 2026

Enrollment change • Real-world evidence • Trial completion • Trial completion date • Trial primary completion date • Dermatology • Rosacea

TERMINATOR: Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial (clinicaltrials.gov) - P4 | N=110 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P4 trial • CNS Disorders • Neuralgia • Neuromyelitis Optica Spectrum Disorder • Pain • Rare Diseases

Real-World Study of Cligabalin(HSK16149) for the Treatment of Rosacea (clinicaltrials.gov) - P=N/A | N=60 | Enrolling by invitation | Sponsor: The First Affiliated Hospital with Nanjing Medical University | Initiation date: May 2026 ➔ Oct 2025

Real-world evidence • Trial initiation date • Dermatology • Rosacea

Efficacy and Safety of Ion Channel Modulators in Painful Diabetic Neuropathy. (PubMed, Diabetes Obes Metab) - "Ion channel modulators, especially calcium channel blockers and sodium channel antagonists, have favourable safety profiles and beneficial effects on reducing pain and improving the quality of life of patients with PDN."

Journal • Diabetic Neuropathy • Pain

Enhanced Efficacy of Crisugabalin 80 Mg/D in Diabetic Peripheral Neuropathic Pain Patients with BMI ≥25 Kg/M²Or Longer Disease Duration: A Post-Hoc Analysis (ENDO 2026) - P2/3 | " This analysis utilized data from a multicenter, randomized, double-blind, placebo- and pregabalin-controlled phase II/III trial (13-week treatment, NCT04647773). This analysis indicated that crisugabalin 80 mg/d (40 mg bid) may provide greater effective analgesia benefit for DPNP patients who are overweight (BMI =25) or have a longer disease duration (>1 year)."

Clinical • Retrospective data • Diabetic Neuropathy • Neuralgia • Obesity • Pain • Peripheral Neuropathic Pain

High-Dose Crisugabalin Significantly Improving the Pain Symptoms in Patients with Diabetic Peripheral Neuropathic Pain (DPNP) (ENDO 2026) - "Interim data suggest significant efficacy and a favorable safety profile of high-dose Crisugabalin in Chinese patients with DPNP."

Clinical • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

High-Dose Crisugabalin Significantly Improving the Pain Symptoms in Patients with Diabetic Peripheral Neuropathic Pain (DPNP) (ADA 2026) - "Interim data suggest significant efficacy and a favorable safety profile of high-dose Crisugabalin in Chinese patients with DPNP."

Clinical • Diabetic Neuropathy • Metabolic Disorders

The Efficacy of Crisugabalin for Sensory Symptoms in Diabetic Peripheral Neuropathy: A Single-Center, Single-Arm, Exploratory Study (ADA 2026) - "Crisugabalin demonstrated significant improvement in TCNS and favorable tolerability in Chinese patients with DPN-related sensory abnormalities, suggesting its potential as a therapeutic option."

Clinical • Diabetic Neuropathy • Metabolic Disorders • Type 2 Diabetes Mellitus

Enhanced Efficacy of Crisugabalin 80 mg/day in Diabetic Peripheral Neuropathic Pain Patients with BMI ≥25 kg/m² or Longer Disease Duration: A Post Hoc Analysis (ADA 2026) - P2/3 | "This post-hoc analysis aimed to explore the efficacy of crisugabalin 80 mg/d (40 mg bid) across different patient subgroups to inform personalized dosing strategies. This analysis utilized data from a multicenter, randomized, double-blind, placebo- and pregabalin-controlled phase II/III trial (13-week treatment, NCT04647773). This analysis indicated that crisugabalin 80 mg/d (40 mg bid) may provide greater effective analgesia benefit for DPNP patients who are overweight (BMI ≥25) or have a longer disease duration (>1 year)."

Clinical • Retrospective data • Diabetic Neuropathy • Metabolic Disorders • Obesity

Real-World Study of Cligabalin for the Treatment of Neurogenic Rosacea (clinicaltrials.gov) - P=N/A | N=60 | Enrolling by invitation | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New trial • Real-world evidence • Dermatology • Rosacea

Crisugabalin Combined with Acetyl-Levo-Carnitine for Diabetic Peripheral Neuropathic Pain: A Phase 2 Randomized Controlled Trial. (PubMed, J Pain Res) - P=N/A | "This combination therapy may be more effective than standard ALA treatment. (Trial registration: ClinicalTrials.gov identifier, NCT06122012)."

Clinical • Journal • P2 data • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Exploratory Study on the Efficacy of Crisugabalin in the Treatment of Chemotherapy-Induced Neuropathic Pain (ChiCTR) - P=N/A | N=20 | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New trial • Neuralgia • Pain

A study on the efficacy and safety of Crisugabalin Besilate Capsules in patients with chronic kidney disease associated pruritus (ChiCTR) - P4 | N=20 | Sponsor: Chu Hsien-I Memorial Hospital of Tianjin Medical University; Chu Hsien-I Memorial Hospital of Tianjin Medical University

New P4 trial • Chronic Kidney Disease • Dermatology • Nephrology • Pruritus • Renal Disease

Efficacy and Safety of Crisugabalin in Patients With Moderate-to-Severe Central Neuropathic Pain: A Phase 3 Randomized Clinical Trial (AAN 2026) - P3 | "Conclusions Crisugabalin significantly reduced pain, improved sleep, mood and quality of life with a well-tolerated safety profiles in cNP patients. These results support crisugabalin as an effective and safe therapeutic option for cNP patients."

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Central Neuropathic Pain • Depression • Musculoskeletal Pain • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

Exploratory Clinical Study of Clecigabine in the Treatment of Rosacea (ChiCTR) - P4 | N=27 | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New P4 trial • Dermatology • Rosacea

Is Crisugabalin Signaling the Arrival of a Third Generation of α2δ Ligands? (PubMed, CNS Drugs) - "Although current evidence is geographically limited and comparative data with established α2δ ligands are lacking, crisugabalin represents a potential evolutionary refinement that may contribute to the future development of the α2δ class. Its clinical role will depend on broader validation and real-world performance."

Journal • Review • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Long-Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52-Week, Multicenter, Single-Arm Trial. (PubMed, J Diabetes Res) - P3 | "In summary, crisugabalin at 80 mg/day was well tolerated and demonstrated sustained analgesic activities."

Journal • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease (clinicaltrials.gov) - P4 | N=166 | Active, not recruiting | Sponsor: Guangdong Provincial People's Hospital

New P4 trial • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease

The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study. (PubMed, J Pain Res) - P=N/A | "Pregabalin, a first-line treatment, offers incomplete efficacy for many and is associated with dose-limiting central nervous system adverse effects. Clinical Trials.gov identifier: NCT07196657. Registered on September 29, 2025 (https://www.clinicaltrials.gov/search?term=NCT07196657)."

Journal • CNS Disorders • Depression • Fibromyalgia • Musculoskeletal Pain • Neuralgia • Pain • Psychiatry • Rheumatology

Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Beijing Friendship Hospital

New P1 trial • Movement Disorders • Restless Legs Syndrome • Sleep Disorder