BioequivalencePhase 1NCT06987773

Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions

A Phase 1 study testing RLF-OD032 100 mg/mL oral suspension and Kuvan 100 MG Powder for Oral Solution in people with Bioequivalence, run by APR Applied Pharma Research s.a. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in healthy Participants. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence
What is being tested?: RLF-OD032 100 mg/mL oral suspension and Kuvan 100 MG Powder for Oral Solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteCanada
Study dates: 20 Aug 2025to 28 Oct 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female participants, light smokers (no more than 10 cigarettes daily) or non-smokers, from 18 to 50 years of age.
BMI ≥18.5 and ≤30 kg/m2 and weight ≥50.0 and ≤100.0 kg for males and ≥45.0 and ≤100.0 kg for females
Females may be of childbearing or non-childbearing potential:
Childbearing potential:
Physically capable of becoming pregnant
Non-childbearing potential:

Show all 11Show fewer

Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation) at least three (3) months prior to first drug administration; and/or;
Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and a FSH value consistent with being postmenopausal).
Willing to use acceptable, effective methods of contraception.
Able to tolerate venipuncture.
Be informed of the nature of the study and give written consent prior to any study procedure.

Who cannot join

History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
Clinically significant illness and/or surgery.
Known or suspected carcinoma.
History of hypersensitivity or idiosyncratic reaction to sapropterin dihydrochloride or any other drug substances with similar activity.
History of or predisposition to seizure which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
History of upper gastrointestinal (GI) mucosal inflammation, esophagitis, gastritis, pharyngitis, or oropharyngeal pain, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.

Show all 46Show fewer

History of abuse of medicinal product or drugs within the last three (3) years.
History of alcohol addiction requiring treatment.
History or presence of alcoholism within the last three (3) years. (>40 g ethanol/day or >10 units per week [one (1) unit =150 mL of wine, or 360 mL of beer, or 45 mL of 45% alcohol])
History of recreational use of soft drugs (such as marijuana) within one (1) month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within three (3) months prior to screening.
Use of St. John's wort within 30 days prior to the first drug administration.
History of clinically significant lactose, galactose, or fructose intolerance.
Presence of hepatic or renal dysfunction.
Presence of mouth piercings (object or hole), presence of non-removable dentures and orthodontic appliances (e.g., braces, retainers), or any other alteration to the mouth that may be deemed by the Investigator to compromise drug delivery.
Note: Dental fillings, crowns, bridges, and implants are permitted as they are not considered to compromise drug delivery.
History of malabsorption within the last year or presence of clinically significant gastrointestinal (GI) disease.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants).
Difficulty fasting or consuming high-fat, high-calorie or standard meals.
Regularly smokes more than 10 cigarettes per day within 6 months prior to the first drug administration.
Participants who received an implanted or injected (depot injection) medication, including hormonal contraceptives, within three (3) months prior to the first drug administration.
Females who:
Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within six (6) months prior to the first drug administration;
Have discontinued or changed the use of oral or patch hormonal contraceptives within one (1) month prior to the first drug administration;
Are pregnant (serum β-hCG consistent with pregnancy); or
Are breast-feeding.
Donation or loss of whole blood (including clinical trials):
≥50 mL and <500 mL within 30 days prior to the first drug administration; or
≥500 mL within 56 days prior to the first drug administration.
Donation of plasma within seven (7) days prior to dosing.
Participation in a clinical trial that involved administration of a biological product within 90 days prior to the first drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize participant safety or the integrity of the study results.
Participation in a clinical trial that involved administration of an investigational medicinal product, marketed drug or device within 30 days prior to the first drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize participant safety or the integrity of the study results.
On a special diet within 30 days prior to the first drug administration (e.g., liquid, protein, raw food diet).
Have had a tattoo or body piercing within 30 days prior to the first drug administration.
Have clinically significant findings in vital signs measurements and systolic blood pressure (SBP) <90 mmHg or >150 mmHg and diastolic blood pressure (DBP) <50 or >90 mmHg, or PR <50 or >100 bpm). Vitals signs may be repeated up to two (2) times, to determine if the values are significantly abnormal.
Have clinically significant findings in a 12-lead ECG. ECG readings may be repeated up to two times, to determine if the values are significantly abnormal.
Have clinically significant abnormal laboratory values. Laboratory tests may be repeated up to two (2) times, to determine if the values are significantly abnormal.
Have significant diseases.
Use of any of the following drugs within 30 days prior to drug administration:
Breast cancer resistance protein (BCRP) substrates (e.g., rosuvastatin);
Drugs affecting nitric oxide-mediated vasorelaxation (e.g., PDE-5 inhibitors, sildenafil, vardenafil, or tadalafil);
Folate synthesis inhibitors (e.g. methotrexate, valproic acid, phenobarbital, or trimethoprim);
Levodopa; or
Drugs which alter GI pH/movement (e.g., omeprazole, ranitidine).
Use of vaccine including COVID-19 vaccine within 14 days prior to the first drug administration.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pharma Medica Research Inc. 4770 Sheppard Ave E,
Toronto, Ontario, M1S3V6

Other trials in Canada

About this study

Official title: A Pivotal, Phase 1, Randomized, Open-Label, Single-Dose, Two-Way Crossover, Bioequivalence Study of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) and Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution in Healthy Participants Under Fed Conditions

Read the detailed description

In each period, subjects will receive a single 10 mg/kg dose of sapropterin dihydrochloride on Day 1, under fed conditions, followed by 24 hours of PK sampling.

The study will include a screening visit from Day -30 to Day -1. In each period, eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses.

Conditions: Bioequivalence
Being tested: RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RLF-OD032 100 mg/mL oral suspensionDrug
Sapropterin dihydrochloride
Kuvan 100 MG Powder for Oral SolutionDrug
Sapropterin dihydrochloride

Study groups in NCT06987773
Study group	Role	What they receive
AB	Other	A) A single 10 mg/kg dose of a 100 mg/mL oral suspension of sapropterin dihydrochloride (RLF-OD032) , administered under fed conditions without water followed by B) A single 10 mg/kg dose of a 100 mg powder for oral solution of the Reference Product (Kuvan) , dissolved in water, administered under fed conditions with water Receives: Drug: RLF-OD032 100 mg/mL oral suspension; Drug: Kuvan 100 MG Powder for Oral Solution
BA	Other	B) A single 10 mg/kg dose of a 100 mg powder for oral solution of the Reference Product (Kuvan) , dissolved in water, administered under fed conditions with water followed by A) A single 10 mg/kg dose of a 100 mg/mL oral suspension of sapropterin dihydrochloride (RLF-OD032), administered under fed conditions without water Receives: Drug: RLF-OD032 100 mg/mL oral suspension; Drug: Kuvan 100 MG Powder for Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Uncorrected and Baseline-corrected Sapropterin AUCt
The area under the analyte concentration versus time curve from time zero to the time of the last measurable analyte concentration (t)
Measured: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
Uncorrected and Baseline-corrected Sapropterin AUCinf
The area under the analyte concentration versus time curve from time zero to infinity
Measured: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
Uncorrected and Baseline-corrected Sapropterin Cmax
Maximum measured plasma analyte concentration over the sampling period
Measured: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)

Secondary outcomes (2)

Uncorrected and Baseline-corrected Sapropterin Tmax
Time of the maximum measured analyte concentration over the sampling period
Measured: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
Uncorrected and Baseline-corrected Sapropterin Tlag
Time of observation prior to the first observation with a measurable (non-zero) concentration
Measured: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 202528 Oct 2025

First posted23 May 2025
Study start20 Aug 2025
Primary completion29 Aug 2025
Study completion28 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BioequivalenceStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Adaptative design In each period, subjects will receive one of the following treatments, according to the randomization scheme: Treatment A: 1 x 10 mg/kg dose of sapropterin dihydrochloride oral suspension 100 mg/mL administered without water under fed conditions. Treatment B: 1 x 10 mg/kg dose of Kuvan (sapropterin dihydrochloride) 100 mg powder for oral solution dissolved in water and administered under fed conditions
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06987773
Sponsor's protocol ID: 2024-5705
Status last verified: Feb 2026
First submitted: 7 May 2025
Last updated: 28 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal, Phase 1, Randomized, Open-Label, Single-Dose, Two-Way Crossover, Bioequivalence Study of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) and Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution in Healthy Participants Under Fed Conditions
ClinicalTrials.gov ID: NCT06987773
Acronym / sponsor ID: 2024-5705
Conditions: Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: APR Applied Pharma Research s.a.University, hospital or other
Study start: 20 Aug 2025 (actual)
Primary completion: 29 Aug 2025 (actual)
Study completion: 28 Oct 2025 (actual)
First posted: 23 May 2025 (actual)
Results: Posted 28 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In each period, subjects will receive a single 10 mg/kg dose of sapropterin dihydrochloride on Day 1, under fed conditions, followed by 24 hours of PK sampling.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Adaptative design In each period, subjects will receive one of the following treatments, according to the randomization scheme: Treatment A: 1 x 10 mg/kg dose of sapropterin dihydrochloride oral suspension 100 mg/mL administered without water under fed conditions. Treatment B: 1 x 10 mg/kg dose of Kuvan (sapropterin dihydrochloride) 100 mg powder for oral solution dissolved in water and administered under fed conditions

Arm	Type	Receives
AB	Other	Drug: RLF-OD032 100 mg/mL oral suspension, Drug: Kuvan 100 MG Powder for Oral SolutionA) A single 10 mg/kg dose of a 100 mg/mL oral suspension of sapropterin dihydrochloride (RLF-OD032) , administered under fed conditions without water followed by B) A single 10 mg/kg dose of a 100 mg powder for oral solution of the Reference Product (Kuvan) , dissolved in water, administered under fed conditions with water
BA	Other	Drug: RLF-OD032 100 mg/mL oral suspension, Drug: Kuvan 100 MG Powder for Oral SolutionB) A single 10 mg/kg dose of a 100 mg powder for oral solution of the Reference Product (Kuvan) , dissolved in water, administered under fed conditions with water followed by A) A single 10 mg/kg dose of a 100 mg/mL oral suspension of sapropterin dihydrochloride (RLF-OD032), administered under fed conditions without water

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy male or female participants, light smokers (no more than 10 cigarettes daily) or non-smokers, from 18 to 50 years of age.
BMI ≥18.5 and ≤30 kg/m2 and weight ≥50.0 and ≤100.0 kg for males and ≥45.0 and ≤100.0 kg for females
Females may be of childbearing or non-childbearing potential:
Willing to use acceptable, effective methods of contraception.
Able to tolerate venipuncture.

Key exclusion criteria (46 listed)

History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
Clinically significant illness and/or surgery.
Known or suspected carcinoma.
History of hypersensitivity or idiosyncratic reaction to sapropterin dihydrochloride or any other drug substances with similar activity.
History of or predisposition to seizure which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.

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
RLF-OD032 100 mg/mL oral suspensionSapropterin dihydrochloride	Drug	AB, BA
Kuvan 100 MG Powder for Oral SolutionSapropterin dihydrochloride	Drug	AB, BA

Primary outcome

Uncorrected and Baseline-corrected Sapropterin AUCt
Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
The area under the analyte concentration versus time curve from time zero to the time of the last measurable analyte concentration (t)
Uncorrected and Baseline-corrected Sapropterin AUCinf
Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
The area under the analyte concentration versus time curve from time zero to infinity
Uncorrected and Baseline-corrected Sapropterin Cmax
Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
Maximum measured plasma analyte concentration over the sampling period

2 secondary outcomes

Uncorrected and Baseline-corrected Sapropterin Tmax
Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)
Uncorrected and Baseline-corrected Sapropterin Tlag
Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)

Results and safety

Results posted to the registry on 28 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence AB	21	20
Sequence BA	21	20

Primary outcome: Uncorrected and Baseline-corrected Sapropterin AUCt

Time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points). Mean (Standard Error). Unit: hr*ng/mL

Measure	Treatment A n = 40	Treatment B n = 40
Uncorrected Sapropterin	819.78 (32)	805.79 (29)
baseline-corrected Sapropterin	757.73 (34)	755.15 (29)

Population analysed: One (1) subject exhibited a pre-dose concentration for uncorrected sapropterin greater than 5% of their corresponding Cmax (9.17%) in Period 1 (Treatment A) and was excluded from the statistical dataset.

Primary outcome: Uncorrected and Baseline-corrected Sapropterin AUCinf

Measure	Treatment A n = 40	Treatment B n = 40
Uncorrected Sapropterin	868.74 (31)	850.63 (28)
Baseline-corrected Sapropterin	777.88 (33)	769.56 (28)

Population analysed: AUCinf could not be estimated for one (1) subject following the administration of Treatment A due to poor goodness of fit in the terminal elimination phase and One (1) subject exhibited a pre-dose concentration for uncorrected sapropterin greater than 5% of their corresponding Cmax (9.17%) in Period 1 (Treatment A) and was excluded from the statistical dataset.

Primary outcome: Uncorrected and Baseline-corrected Sapropterin Cmax

Measure	Treatment A n = 40	Treatment B n = 40
Uncorrected Sapropterin	119.25 (42)	124.09 (30)
Baseline-corrected Sapropterin	114.84 (40)	121.97 (30)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks (From ICF signature to the last contact to collect any safety follow-up data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
Treatment B	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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. This study is not recruiting at the moment.

Mark L. Freedman, MD,FRCPC principal investigator

Canada, Ontario - Pharma Medica Research Inc. 4770 Sheppard Ave E

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RLF-OD032 100 mg/mL oral suspension and Kuvan 100 MG Powder for Oral Solution in people with Bioequivalence, run by APR Applied Pharma Research s.a. at 1 site in Canada.

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 11 inclusion and 46 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected and Baseline-corrected Sapropterin AUCt (time frame: Pre-dose (-1, -0.5, and 0-hour) and at 0.333, 0.667, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, and 24 hours post-dose (22 time points)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06987773.

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 28 Apr 2026.