Pulmonary Arterial Hypertension (PAH)Phase 3NCT07632898
Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing IKT-001 in people with Pulmonary Arterial Hypertension (PAH), run by Inhibikase Therapeutics.
Trial summary
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- IKT-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 30 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- IKT-001
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKT-001Drug
IKT-001 tablets for PO administration
| Study group | Role | What they receive |
|---|---|---|
| IKT-001 | Experimental | IKT-001 tablets for PO administration Receives: Drug: IKT-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.
Measured: From baseline to end of study (up to 2 years or availability of commercial product)
Secondary outcomes (2)
Change from baseline in 6-minute walk distance (6MWD)
Measured: From baseline to end of study (up to 2 years or availability of commercial product)
Change from baseline in NT-proBNP
Measured: From baseline to end of study (up to 2 years or availability of commercial product)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start23 Oct 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inhibikase Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632898
- Sponsor's protocol ID
- IKT-001-202
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07632898
- Acronym / sponsor ID
- IKT-001-202
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Inhibikase TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IKT-001 | Experimental | Drug: IKT-001IKT-001 tablets for PO administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Any of the following clinical laboratory values at screening:
- Currently lactating, pregnant or planning on becoming pregnant during the study.
- Receiving treatment with sotatercept.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IKT-001IKT-001 tablets for PO administration | Drug | IKT-001 |
Primary outcome
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.
2 secondary outcomes
Change from baseline in 6-minute walk distance (6MWD)
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
Change from baseline in NT-proBNP
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IKT-001 in people with Pulmonary Arterial Hypertension (PAH), run by Inhibikase Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director, Inhibikase Therapeutics (1-302-295-3800, info@inhibikase.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest (time frame: From baseline to end of study (up to 2 years or availability of commercial product)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.