Idiopathic Pulmonary FibrosisPhase 2NCT07869147
Study of ORJ-001 for the Treatment of IPF
A Phase 2 study testing ORJ-001 in people with Idiopathic Pulmonary Fibrosis, run by Oorja Bio, Inc. at 2 sites in United States.
Trial summary
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- ORJ-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged ≥ 40 years when signing informed consent
- Non-smoker or ex-smoker who has stopped smoking for > 6 months prior to signing informed consent
- Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on HRCT of the chest. The HRCT may be performed at screening or, if available, a historical HRCT obtained within 12 months from screening may be submitted for central review
- FVC of at least 45% of the predicted value and a DLCO, corrected for the hemoglobin level, of at least 25% and no greater than 90% of the predicted value. Note: Each test (FVC and DLCO) may be repeated once after a minimum of 24 hours if the initial result is deemed unreliable by the investigator
- If receiving SOC antifibrotic therapy, participants must be on a stable regimen of a single approved therapy for at least 60 days prior to the screening visit. Participants who have discontinued SOC antifibrotic therapy due to tolerability or lack of response may be enrolled after at least 30 days of discontinuing the SOC antifibrotic therapy.
- Negative serum pregnancy test in women of childbearing potential at the screening visit
Who cannot join
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization
- Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement
- Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio < 0.7 at screening
- Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery)
- Acute IPF exacerbation within 3 months from screening, or during the screening period
- Receiving more than 15 mg per day of prednisone during screening
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials contact
United States2 sites, 2 recruiting
- Recruiting
Innova Pharma Research, LLC
Doral, Florida, 33172
- Recruiting
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
About this study
Official title: A Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Tolerability (Part A), and Efficacy (Part B), of ORJ-001 in Patients With Idiopathic Pulmonary Fibrosis (ORBIT-IPF)
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.
Read the detailed description
This Phase 2a/2b, randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety, tolerability, and efficacy of ORJ-001 administered subcutaneously twice weekly in adults with IPF. The study consists of two parts. Part A will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of two dose levels of ORJ-001 compared with placebo over 12 weeks of treatment. Data from Part A will be reviewed by an independent Data Monitoring Committee to select the dose for Part B. Participants in Part A will not continue into Part B; Part B will enroll a separate cohort of participants. Part B will evaluate the efficacy of the selected ORJ-001 dose compared with placebo, with the primary efficacy endpoint being change from baseline in forced vital capacity (FVC) at Week 12. Secondary and exploratory assessments include percent predicted FVC, time to acute IPF exacerbation, respiratory hospitalization or death, patient-reported outcomes, pharmacokinetics, and biomarkers of fibrosis. Adults aged 40 years or older with confirmed IPF and adequate pulmonary function who are receiving stable antifibrotic standard-of-care therapy, or who have previously discontinued such therapy due to tolerability or lack of response, may be eligible to participate.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- ORJ-001, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, ORBIT, Fibrosing Interstitial Pneumonia, UIP
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORJ-001Drug
ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated.
PlaceboOther
Matching placebo administered by subcutaneous injection twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Part A: ORJ-001 400 mg | Experimental | Participants receive ORJ-001 400 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (400 mg:200 mg:placebo). Receives: Drug: ORJ-001; Other: Placebo |
| Part A: ORJ-001 200 mg | Experimental | Participants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo). Receives: Drug: ORJ-001; Other: Placebo |
| Part A: Placebo | Placebo comparator | Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Receives: Other: Placebo |
| Part B: ORJ-001 (Selected Dose) | Experimental | Participants receive the ORJ-001 dose selected based on Part A safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy data, administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Participants are randomized 1:1 to ORJ-001 or placebo. Receives: Drug: ORJ-001; Other: Placebo |
| Part B: Placebo | Placebo comparator | Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
Number of participants experiencing at least one treatment-emergent adverse event.
Measured: From first dose through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)
Severity of treatment-emergent adverse events as graded according to CTCAE v6.0.
Measured: From first dose through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure measured in millimeters of mercury (mmHg).
Measured: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature
Change from baseline in body temperature measured in degrees Celsius (°C).
Measured: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Heart Rate
Change from baseline in heart rate measured in beats per minute (bpm).
Measured: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Respiratory Rate
Change from baseline in respiratory rate measured in breaths per minute.
Measured: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation
Change from baseline in oxygen saturation measured as percentage (% SpO₂).
Measured: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Corrected QT Interval
Change from baseline in corrected QT interval (QTc) measured by electrocardiogram (ECG) in milliseconds (ms).
Measured: Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.
Part B: Change from Baseline in Forced Vital Capacity (FVC)
Change from baseline in FVC measured by spirometry at Week 12.
Measured: Baseline to Week 12
Secondary outcomes (2)
Part B: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC%)
Change from baseline in percentage of predicted FVC measured by spirometry at Week 12.
Measured: Baseline to Week 12.
Part B: Time to Acute Exacerbation of IPF, Hospitalization for a Respiratory Cause, or Death
Time, in days, to first occurrence of acute IPF exacerbation, hospitalization for a respiratory cause, or death.
Measured: Up to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one treatment arm and remain in that assigned arm throughout the treatment period. In Part A, participants are assigned to ORJ-001 400 mg, ORJ-001 200 mg, or placebo. In Part B, participants are assigned to the selected ORJ-001 dose or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oorja Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oorja Bio Medical Director, Study director, Oorja Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869147
- Sponsor's protocol ID
- ORJ-001-01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Tolerability (Part A), and Efficacy (Part B), of ORJ-001 in Patients With Idiopathic Pulmonary Fibrosis (ORBIT-IPF)
- ClinicalTrials.gov ID
- NCT07869147
- Acronym / sponsor ID
- ORJ-001-01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, ORBIT, Fibrosing Interstitial Pneumonia, UIP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Oorja Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 9 Oct 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.
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.
Detailed description
This Phase 2a/2b, randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety, tolerability, and efficacy of ORJ-001 administered subcutaneously twice weekly in adults with IPF. The study consists of two parts. Part A will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of two dose levels of ORJ-001 compared with placebo over 12 weeks of treatment. Data from Part A will be reviewed by an independent Data Monitoring Committee to select the dose for Part B. Participants in Part A will not continue into Part B; Part B will enroll a separate cohort of participants. Part B will evaluate the efficacy of the selected ORJ-001 dose compared with placebo, with the primary efficacy endpoint being change from baseline in forced vital capacity (FVC) at Week 12. Secondary and exploratory assessments include percent predicted FVC, time to acute IPF exacerbation, respiratory hospitalization or death, patient-reported outcomes, pharmacokinetics, and biomarkers of fibrosis. Adults aged 40 years or older with confirmed IPF and adequate pulmonary function who are receiving stable antifibrotic standard-of-care therapy, or who have previously discontinued such therapy due to tolerability or lack of response, may be eligible to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants are randomized to one treatment arm and remain in that assigned arm throughout the treatment period. In Part A, participants are assigned to ORJ-001 400 mg, ORJ-001 200 mg, or placebo. In Part B, participants are assigned to the selected ORJ-001 dose or placebo.
| Arm | Type | Receives |
|---|---|---|
| Part A: ORJ-001 400 mg | Experimental | Drug: ORJ-001, Other: PlaceboParticipants receive ORJ-001 400 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (400 mg:200 mg:placebo). |
| Part A: ORJ-001 200 mg | Experimental | Drug: ORJ-001, Other: PlaceboParticipants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo). |
| Part A: Placebo | Placebo comparator | Other: PlaceboParticipants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. |
| Part B: ORJ-001 (Selected Dose) | Experimental | Drug: ORJ-001, Other: PlaceboParticipants receive the ORJ-001 dose selected based on Part A safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy data, administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Participants are randomized 1:1 to ORJ-001 or placebo. |
| Part B: Placebo | Placebo comparator | Other: PlaceboParticipants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged ≥ 40 years when signing informed consent
- Non-smoker or ex-smoker who has stopped smoking for > 6 months prior to signing informed consent
- Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on HRCT of the chest. The HRCT may be performed at screening or, if available, a historical HRCT obtained within 12 months from screening may be submitted for central review
- FVC of at least 45% of the predicted value and a DLCO, corrected for the hemoglobin level, of at least 25% and no greater than 90% of the predicted value. Note: Each test (FVC and DLCO) may be repeated once after a minimum of 24 hours if the initial result is deemed unreliable by the investigator
- If receiving SOC antifibrotic therapy, participants must be on a stable regimen of a single approved therapy for at least 60 days prior to the screening visit. Participants who have discontinued SOC antifibrotic therapy due to tolerability or lack of response may be enrolled after at least 30 days of discontinuing the SOC antifibrotic therapy.
Key exclusion criteria (8 listed)
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization
- Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement
- Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio < 0.7 at screening
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 |
|---|---|---|
| ORJ-001ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated. | Drug | Part A: ORJ-001 200 mg, Part A: ORJ-001 400 mg, Part B: ORJ-001 (Selected Dose) |
| PlaceboMatching placebo administered by subcutaneous injection twice weekly. | Other | Part A: ORJ-001 200 mg, Part A: ORJ-001 400 mg, Part A: Placebo, Part B: ORJ-001 (Selected Dose), Part B: Placebo |
Primary outcome
Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Number of participants experiencing at least one treatment-emergent adverse event.
Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Severity of treatment-emergent adverse events as graded according to CTCAE v6.0.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in systolic blood pressure measured in millimeters of mercury (mmHg).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in body temperature measured in degrees Celsius (°C).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Heart Rate
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in heart rate measured in beats per minute (bpm).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Respiratory Rate
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in respiratory rate measured in breaths per minute.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in oxygen saturation measured as percentage (% SpO₂).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Corrected QT Interval
Time frame: Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.
Change from baseline in corrected QT interval (QTc) measured by electrocardiogram (ECG) in milliseconds (ms).
Part B: Change from Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline to Week 12
Change from baseline in FVC measured by spirometry at Week 12.
2 secondary outcomes
Part B: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC%)
Time frame: Baseline to Week 12.
Part B: Time to Acute Exacerbation of IPF, Hospitalization for a Respiratory Cause, or Death
Time frame: Up to Week 12.
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 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Clinical Trials contact
Oorja Bio Medical Director study director
Oorja Bio, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORJ-001 in people with Idiopathic Pulmonary Fibrosis, run by Oorja Bio, Inc. at 2 sites in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Clinical Trials (1 (832) 400-6140, clinicaltrials@oorjabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs) (time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.). The study lists 9 primary outcomes in all. 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 15 Oct 2026.