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New PAH drug IKT-001 moves to Long-Term safety check

NCT ID NCT07632898

Disease control Sponsor: Inhibikase Therapeutics 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking the long-term safety of a daily pill called IKT-001 for people with pulmonary arterial hypertension (PAH), a serious lung condition. About 484 adults who have already completed an earlier IKT-001 study will take the drug for an extended period. Researchers will track side effects and also measure how far patients can walk in 6 minutes and a heart stress marker in the blood.

What this could mean

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

Active substance
IKT-001 (tablet taken by mouth once daily)
What this could lead to
If successful, this could confirm that IKT-001 is safe enough for long-term use in managing pulmonary arterial hypertension.
What could go wrong
This is an open-label extension study with no placebo group, so results may be less reliable. It only includes people who tolerated IKT-001 before, which may not reflect the broader patient population.

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

About 484 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

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: * Capable of giving signed informed consent. * Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001. Exclusion Criteria: * Any of the following clinical laboratory values at screening: * ALT or AST levels \>3× the ULN * Bilirubin levels \>2× the ULN * ANC \<1.2 ×10\^9 cells/L, hemoglobin \<9 g/dL, hematocrit \<30%, or platelets \<75 × 10\^9 cells/L * Absolute eGFR \<30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021) * Currently lactating, pregnant or planning on becoming pregnant during the study. * Receiving treatment with sotatercept.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

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

Pulmonary arterial hypertension (PAH)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

Study contacts

  • Contact

    Email: •••••@•••••

More trials for these conditions

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