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New acne pill tested for Long-Term safety in 240 patients

NCT ID NCT06248008

Disease control Sponsor: Ascletis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the long-term safety of a daily pill called ASC40 (Denifanstat) in 240 people with moderate to severe acne who had already completed a previous phase 3 trial. Participants took the drug once daily for up to 40 weeks, with regular blood tests and checkups to monitor for side effects. The main goal was to see how many people experienced treatment-related problems, not to measure how well the drug cleared acne.

What this could mean

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

Active substance
ASC40 (Denifanstat) tablets
What this could lead to
If successful, this could confirm that ASC40 is safe for long-term use, potentially offering a new daily pill option for managing moderate to severe acne.
What could go wrong
This is an extension study focused on safety, not on proving how well the drug works. Side effects or lack of lasting benefit may limit its use.

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

240 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2025

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 40 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: * Participants who have successfully completed a 12-week Phase III study of ASC40-303; * Have fully understood this research and voluntarily signed the informed consent; * The fertile male and female subjects of reproductive age agreed to use effective contraception from the time they signed the informed consent until 3 months after the final administration of the investigationa drug; * Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule. Exclusion Criteria: * Discontinue participation in the ASC40-303 Phase III study for any reason; * Are receiving/planning to receive any systemic acne medications, systemic retinoids, systemic corticosteroids, or any androgen/antiandrogen therapy (e.g., testosterone, spironolactone); * Pregnant, nursing, or planning a pregnancy during the study period; * Have major complications (including clinically significant abnormalities in clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

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

Acne

Contacts and locations

Locations

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200000, China

More trials for these conditions

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