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New nerve pain drug shows promise in Year-Long trial

NCT ID NCT05890053

Symptom relief Sponsor: Haisco Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the long-term safety and effectiveness of HSK16149, a drug for nerve pain, in 301 Chinese patients over 52 weeks. All participants had previously completed a shorter trial and tolerated the drug. Researchers tracked side effects and pain scores to see if the drug remains safe and helpful over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK16149
What this could lead to
If successful, this could provide a long-term treatment option for people with nerve pain.
What could go wrong
This is an extension study, so participants already tolerated the drug. However, long-term side effects are still being monitored, and results may not apply to non-Chinese populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

301 people

The number who actually took part.

Started

Feb 2022

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301. 2. Able to understand and voluntarily sign informed consent. Exclusion Criteria: 1. Medication compliance was \< 80% in double-blind studies. 2. In double-blind study, EOT visit (V10) eGFR\< 60 mL/min//1.73m2 3. Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study. 4. Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening \[further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded). 5. Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period. 6. The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.

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Conditions

The condition(s) this trial relates to.

peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral neuropathic pain

Contacts and locations

Locations

  • Baotou Central Hospital

    Baotou, Neimenggu, China

  • Beijing Pinggu District Hospital

    Beijing, Beijing Municipality, China

  • Cangzhou People's Hospital

    Cangzhou, Hebei, China

  • Emergency General Hospital

    Beijing, Beijing Municipality, China

  • Jinan Central Hospital

    Jinan, Shandong, China

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng, Henan, China

  • Nanjing First People's Hospital

    Nanjing, Jiangsu, China

  • Nanyang First People's Hospital

    Nanyang, Henan, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, China

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The Second People's Hospital of Yibin

    Yibin, Sichuan, China

  • The Third Hospital of Hebei Medical University

    Shijiangzhuang, Hebei, China

  • The Three Gorges Hospital Affiliated to Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • Wuhan Central Hospital

    Wuhan, Hubei, China

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.