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Could an old allergy drug shrink enlarged prostates?

NCT ID NCT06689514

Disease control Sponsor: Yifeng Jing Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests whether tranilast, a drug currently used for allergies, can help men with moderate to severe enlarged prostate (BPH). The study will include 30 men aged 55-75 with prostate volumes over 40mL and urinary symptoms. Participants will receive standard care plus either a low or high dose of tranilast to see if it safely reduces prostate size and improves symptoms.

What this could mean

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

Active substance
Tranilast
What this could lead to
If it works, this could point toward a new non-surgical treatment for enlarged prostate, reducing symptoms and improving quality of life.
What could go wrong
This is a very early, small trial with only 30 participants. It may not show enough benefit or could have side effects. Results may not apply to all patients.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

55 to 75 years

Sex

Male participants only

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: * Patients with benign prostatic hyperplasia aged 55 to 75 years old; * The patient's prostate volume is greater than 40mL; * There is urinary obstruction, with an International Prostate Symptom Score (IPSS) greater than or equal to 8 points, and a maximum urinary flow rate of less than 15ml/s (urinary flow rate is not measured in patients with indwelling catheters). Exclusion Criteria: * Urinary disorders caused by neurogenic diseases; * Acute urinary tract infections have not been effectively controlled; * There are factors of lower urinary tract obstruction other than BPH, such as urethral stricture; * History of radiation therapy or surgery in the lower urinary tract or pelvic cavity; * Have ever suffered from tumor of urinary system, or suspected of suffering from tumor of urinary system (such as bladder cancer cancer, prostate cancer); * Current or past liver function abnormalities (exceeding the test reference value limit); * Abnormal renal function (exceeding the test reference value limit); * Currently taking warfarin; * Allergic to tranilast or drug preparations; * Suffering from other major diseases (malignant tumors, autoimmune diseases, angina pectoris, heart failure, severe respiratory and digestive diseases, etc.), and not yet clinically cured; * Other researchers believe that patients who are not suitable to participate in this trial.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

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

Prostatic hypertrophy, benign

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    RECRUITING

    Shanghai, Outside U.S./Canada, 200086, China

  • Shanghai General Hospital

    NOT_YET_RECRUITING

    Shanghai, 200086, China

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