crisugabalin (HSK16149) / Haisco - LARVOL DELTA

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

The Efficacy of Crisugabalin for Sensory Symptoms in Diabetic Peripheral Neuropathy: A Single-Center, Single-Arm, Exploratory Study (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Diabetic Neuropathy • Metabolic Disorders

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) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Retrospective data • Diabetic Neuropathy • Metabolic Disorders

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

Efficacy and Safety of Crisugabalin in Patients With Moderate-to-Severe Central Neuropathic Pain: A Phase 3 Randomized Clinical Trial (AAN 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Central Neuropathic Pain • Neuralgia • Pain

An Observational Cohort Study of Early Response to Therapy and Safety of Crisugabalin Besilate Capsules for the Treatment of Neuropathic Pain in the Real World (ChiCTR) - P4 | N=1000 | Recruiting | Sponsor: The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university | Not yet recruiting ➔ Recruiting

Enrollment open • Neuralgia • Pain

A Multicenter, Observational Study of Crisugabalin in the Real-World Treatment of Patients with Paresthesia Caused by Diabetic Distal Symmetric Polyneuropathy (ChiCTR) - P4 | N=138 | Not yet recruiting | Sponsor: Guangdong Provincial Hospital of Chinese Medicine; Guangdong Provincial Hospital of Chinese Medicine

New P4 trial • Pain

Efficacy and Safety of Crisugabalin in Patients with Refractory Chronic Cough: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ChiCTR) - P=N/A | N=70 | Not yet recruiting | Sponsor: Shanghai Tongji Hospital; Shanghai Tongji Hospital

New trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Observational cohort study on the efficacy and safety of Crisugabalin Besilate Capsules in treating neuropathic pain based on pain mechanisms in the real world (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: China-Japan Friendship Hospital; China-Japan Friendship Hospital

New trial • Neuralgia • Pain

Efficacy and Safety of Crisugabalin versus Gabapentin in the Treatment of Refractory Chronic Cough: A Randomized Controlled Trial (ChiCTR) - P=N/A | N=105 | Not yet recruiting | Sponsor: Tongji Hospital Affiliated to Tongji University; Tongji Hospital Affiliated to Tongji University

New trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

CEASE-GAD: Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: Anhui Medical University

New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

The Analgesic Efficacy and Safety of Crisugabalin in Patients With Herpes Zoster (clinicaltrials.gov) - P=N/A | N=750 | Recruiting | Sponsor: Beijing Tiantan Hospital

New trial • Herpes Zoster • Pain • Varicella Zoster

Structural and Computational Insights into the Mechanism of the Superior Pharmacological Activity of Crisugabalin: A Third-Generation Cavα2δ1 Ligand. (PubMed, J Chem Inf Model) - "Crisugabalin, a recently approved third-generation GABA analogue with a unique cage-like tricyclic scaffold, shows superior efficacy and safety over pregabalin and mirogabalin for treating neuropathic pain...Cryo-EM structures demonstrated crisugabalin's superior binding affinity for α2δ1 over gabapentin and l-leucine, driven by enhanced hydrogen bonding and hydrophobic contacts, alongside volumetric expansion of the l-leucine binding pocket...These findings establish the cage-like tricyclic motif as a novel pharmacophore that simultaneously optimizes binding entropy and enthalpy, providing a blueprint for next-generation voltage-gated calcium channel modulators. MD, τRAMD, and MM-GBSA used in this study are powerful computational tools for rational drug design, particularly for optimizing compounds with prolonged target residence times."

Journal • Neuralgia • Pain

The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=1116 | Recruiting | Sponsor: Beijing Tiantan Hospital | N=362 ➔ 1116

Enrollment change • Monotherapy • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

New Tricyclic γ‑Aminobutyric Acid Analogue HSK16149: A Ca2+ Channel α2‑δ Ligand for Treating Neuropathic Pain. (PubMed, ACS Med Chem Lett) - "Pregabalin and gabapentin are currently first-line treatments for neuropathic pain, but common adverse effects such as dizziness and somnolence frequently lead to treatment discontinuation. HSK16149 also demonstrated superior antihypersensitivity or antiallodynic/hyperalgesic effects compared to the commonly used pregabalin as the control and has the potential to minimize CNS side effects with good tolerability. Based on its exceptional preclinical characteristics, HSK16149 was chosen for further development to provide a more effective and safer drug for patients enduring neuropathic pain."

Journal • Immunology • Neuralgia • Pain

The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=362 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Evaluation of the Efficacy and Safety of Crisugabalin Capsules versus Placebo and Venlafaxine Extended-Release (XR) Capsules in Chinese Patients with Generalized Anxiety Disorder: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Clinical Trial (CEASE-GAD). (ChiCTR) - P4 | N=216 | Not yet recruiting | Sponsor: The first affiliated hospital of anhui medical university; The first affiliated hospital of anhui medical university

New P4 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Safety and pharmacokinetics of a novel potent GABA analogue crisugabalin in Chinese subjects with various degrees of renal impairment. (PubMed, Br J Clin Pharmacol) - "For patients with GFR < 60 mL/min, dosage adjustments of crisugabalin should be considered. To maintain comparable plasma drug concentrations in patients with impaired renal function, it is recommended that crisugabalin doses be decreased by approximately 50% for every 50% decline in GFR."

Journal • PK/PD data • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain • Renal Disease

The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=362 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

Monotherapy • New trial • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia (clinicaltrials.gov) - P3 | N=301 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of Crisugabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain and Inadequate Response to Pregabalin—A Phase 2 Randomized Clinical Trial (ADA 2025) - "In Chinese patients with DPNP who had an inadequate response to Pregabalin, Crisugabalin was superior to Pregabalin in reducing DPNP symptoms and was well tolerated."

Clinical • P2 data • Diabetic Neuropathy • Metabolic Disorders

An Observational Cohort Study of Early Response to Therapy and Safety of Crisugabalin Besilate Capsules for the Treatment of Neuropathic Pain in the Real World (ChiCTR) - P4 | N=1000 | Not yet recruiting | Sponsor: The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university

New P4 trial • Real-world evidence • Neuralgia • Pain

An observational cohort study of the efficacy and safety of crisugabalin besilate capsules for the treatment of patients with acute herpes zoster in the real world (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Hangzhou Third People's Hospital; Hangzhou Third People's Hospital

New trial • Real-world evidence • Herpes Zoster • Varicella Zoster