COVID-19Phase 2/3NCT04467840
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
A Phase 2/3 study testing Opaganib in people with COVID-19 and Lung Infection, run by RedHill Biopharma Limited at 57 sites in 10 countries.
Trial summary
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Lung Infection
- What is being tested?
- Opaganib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 57 sitesin 10 countries
- Study dates
- 21 Aug 2020to 18 Jul 2021
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female ≥18 to ≤80 years of age
- Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan. that diagnosed COVID-19 pneumonia. Pharyngeal samples collected either at screening or within 7-days prior to screening for the same ongoing COVID-19 pneumonia illness are acceptable
- The patient requires, at baseline, high flow supplemental oxygen or positive pressure ventilation or is receiving oxygen via face mask, such as a non-rebreather or reservoir mask, capable of delivering high concentrations of oxygen
- Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
- The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
Who cannot join
- Any co-morbidity that may add risk to the treatment in the judgment of the investigator, particularly patients with known cardiac conditions, and serious neuropsychiatric conditions such as psychosis or major depression
- Requiring intubation and mechanical ventilation at baseline
- Patient has a 'Do Not Intubate' and/or 'Do Not Resuscitate' order in place
- Oxygen saturation >95% on room air
- Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- Patient is, in the investigator's clinical judgement, unlikely to survive >72 hours
Show all 21Show fewer
- Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women .
- Unwillingness or inability to comply with procedures required in this protocol.
- Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia's formula (QTcF)
- AST (SGOT) or ALT (SGPT) > 2.0 x upper limit of normal (ULN)
- Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
- Serum creatinine >2.0 X ULN
- Absolute neutrophil count <1000 cells/mm3
- Platelet count <75,000/mm3
- Hemoglobin <8.0 g/dL
- Medications that are sensitive substrates, or substrates with a narrow therapeutic range, for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 CYP2D6 , CYP3A4, P-gP, BCRP and OATP1B1 should be avoided with opaganib
- Moderate or strong inhibitors of CYP1A2, CYP3A4, CYP2D6 or P-gP or moderate to strong inducers of CYP3A4 and CYP1A2 are prohibited
- Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism
- Current drug or alcohol abuse
- Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
- Treatment with any medication that causes QT prolongation within seven days, or 5 half-lives, whichever is longest, prior to initiation of study drug, or intention to use them throughout the study, including but not limited to: amiodarone, amitriptyline, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilde, ondansetron or other 5-HT3 receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolone, ranolazine, risperidone, sotaloland tolteridine. Investigators are directed to the following up-to-date web site listing QT prolonging drugs: https://www.crediblemeds.org/index.php/drugsearch
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
Russia15 sites
ABC-201 Site 110
Barnaul
ABC-201 Site 122
Kirovsk
ABC-201 Site 101
Moscow
ABC-201 Site 132
Moscow
ABC-201 Site 120
Murmansk
ABC-201 Site 103
Ryazan
ABC-201 Site 114
Ryazan
ABC-201 Site 109
Saint Petersburg
ABC-201 Site 111
Saint Petersburg
ABC-201 Site 129
Saint Petersburg
ABC-201 Site 108
Saratov
ABC-201 Site 102
Smolensk
ABC-201 Site 104
Tver'
ABC-201 Site 118
Volgograd
ABC-201 Site 112
Yaroslavl
Brazil10 sites
ABC-201 Site 408
Belo Horizonte
ABC-201 Site 411
Belo Horizonte
ABC-201 Site 405
Joinville
ABC-201 Site 404
Paraná
ABC-201 Site 410
Passo Fundo
ABC-201 Site 409
Porto Alegre
ABC-201 Site 402
São Bernardo do Campo
ABC-201 Site 401
São Paulo
ABC-201 Site 403
São Paulo
ABC-201 Site 407
Tubarão
Israel8 sites
ABC-201 Site 702
Ashdod
ABC-201 Site 708
Ashkelon, Ashketon
ABC-201 Site 704
Holon
ABC-201 Site 701
Jerusalem
ABC-201,Site 709
Kfar Saba
ABC-201 Site 705
Nahariya
ABC-201 Site 706
Nazareth
ABC-201 Site 703
Safed
Poland8 sites
ABC-201 Site 303
Bolesławiec
ABC-201 Site 306
Katowice
ABC-201 Site 304
Koszalin
ABC-201 Site 308
Lodz
ABC-201 Site 307
Lublin
ABC-201 Site 302
Ostróda
ABC-201 Site 301
Racibórz
ABC-201 Site 305
Wroclaw
Colombia5 sites
ABC-201 Site 603
Bogotá
ABC-201 Site 605
Cundinamarca
ABC-201 Site 604
Medellín, Antioquia
ABC-201 Site 602
Medellín
ABC-201 Site 601
Santiago de Cali
Italy4 sites
ABC-201 Site 203
Alessandria
ABC-201 Site 201
Lecco
ABC-201 Site 202
Milan
ABC-201 Site 204
Torino
United Kingdom3 sites
ABC-201 Site 253
Antrim
ABC-201 Site 251
Gillingham
ABC-201 Site 252
Taunton
About this study
Official title: Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized With Severe SARS-CoV-2 Positive Pneumonia
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.
Read the detailed description
This is a phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study with an adaptive design that will utilize a futility assessment. The study is planned be performed worldwide in up to approximately 80 clinical sites.
After informed consent is obtained, patients will enter a screening phase for no more than 3 days, to determine eligibility. Approximately 464 eligible patients will be randomized and receive either opaganib added to standard of care, or matching placebo added to standard of care, in a randomization ratio of 1:1. Treatment assignments will remain blinded to the patient, investigator and hospital staff, as well as the sponsor. As the approval and/or guidance for treating COVID-19 are evolving, for this protocol, standard of care will be defined by the recommended schemes of treatment according to the severity of the disease, taking into consideration regulatory approvals in one or more regions.
Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). All participants will be followed up for 28 days after their last dose of study drug, which may occur at Day 14 or after premature study drug discontinuation, based upon patient or physician determination.
- Conditions
- COVID-19, Lung Infection
- Being tested
- Opaganib, Placebo
- Keywords
- Therapeutic Use
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
Also called Yeliva, ABC294640
Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).
PlaceboDrug
Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).
| Study group | Role | What they receive |
|---|---|---|
| Opaganib | Experimental | In addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube. Receives: Drug: Opaganib |
| Placebo | Placebo comparator | In addition to standard of care, a matching placebo will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. Where required this may be made into a suspension form and may be administered by nasogastric tube. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplemental Oxygen Requirement
To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.
Measured: 14 days maintained up to 42 days
Secondary outcomes (9)
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42
Compare ≥2 category improvement on the WHO Ordinal Scale for Clinical Improvement from 0(uninfected) to 8(death) for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit, and failure otherwise.
Measured: 14 days maintained up to 42 days
Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0
Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement to determine time to recovery as defined by improvement to a score of 3 or less on the WHO Ordinal Scale for Clinical Improvement with a scale ranging from 0 (uninfected) to 8 (death)
Measured: 14 days maintained up to 42 days
Number of Participants With Low Oxygen Flow Via Nasal Cannula
To compare the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option between subjects taking opaganib and those on placebo.
Measured: 14 days maintained up to 42 days
Time to Discharge From Hospital Measured at 14 Days
Time to subject discharge from hospital
Measured: 14 days
Patients Requiring Intubation and Mechanical Ventilation by Day 42
To compare the proportion of patients requiring intubation and mechanical ventilation between subjects taking opaganib and those on placebo.
Measured: 42 days
Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14
To compare the number of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.
Measured: 14 days
Patients With Negative Swabs for SARS-CoV-2 at Day 14
To compare the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.
Measured: 14 days
Mortality Due to Any Cause
To compare mortality 28 days post-baseline between subjects taking opaganib and those taking placebo
Measured: 28 days
Mortality Due to Any Cause
To compare mortality 42 days post-baseline between subjects taking opaganib and those taking placebo
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start21 Aug 2020
- Primary completion18 Jul 2021
- Study completion18 Jul 2021
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 COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark L Levitt, MD, Study director, RedHill Biopharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467840
- Sponsor's protocol ID
- ABC-201
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2020
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized With Severe SARS-CoV-2 Positive Pneumonia
- ClinicalTrials.gov ID
- NCT04467840
- Acronym / sponsor ID
- ABC-201
- Conditions
- COVID-19, Lung Infection
- Keywords
- Therapeutic Use
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 19 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.
Detailed description
This is a phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study with an adaptive design that will utilize a futility assessment. The study is planned be performed worldwide in up to approximately 80 clinical sites.
After informed consent is obtained, patients will enter a screening phase for no more than 3 days, to determine eligibility. Approximately 464 eligible patients will be randomized and receive either opaganib added to standard of care, or matching placebo added to standard of care, in a randomization ratio of 1:1. Treatment assignments will remain blinded to the patient, investigator and hospital staff, as well as the sponsor. As the approval and/or guidance for treating COVID-19 are evolving, for this protocol, standard of care will be defined by the recommended schemes of treatment according to the severity of the disease, taking into consideration regulatory approvals in one or more regions.
Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). All participants will be followed up for 28 days after their last dose of study drug, which may occur at Day 14 or after premature study drug discontinuation, based upon patient or physician determination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opaganib | Experimental | Drug: OpaganibIn addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube. |
| Placebo | Placebo comparator | Drug: PlaceboIn addition to standard of care, a matching placebo will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. Where required this may be made into a suspension form and may be administered by nasogastric tube. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female ≥18 to ≤80 years of age
- Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan. that diagnosed COVID-19 pneumonia. Pharyngeal samples collected either at screening or within 7-days prior to screening for the same ongoing COVID-19 pneumonia illness are acceptable
- The patient requires, at baseline, high flow supplemental oxygen or positive pressure ventilation or is receiving oxygen via face mask, such as a non-rebreather or reservoir mask, capable of delivering high concentrations of oxygen
- Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
- The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
Key exclusion criteria (21 listed)
- Any co-morbidity that may add risk to the treatment in the judgment of the investigator, particularly patients with known cardiac conditions, and serious neuropsychiatric conditions such as psychosis or major depression
- Requiring intubation and mechanical ventilation at baseline
- Patient has a 'Do Not Intubate' and/or 'Do Not Resuscitate' order in place
- Oxygen saturation >95% on room air
- Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
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 |
|---|---|---|
| OpaganibAlso: Yeliva, ABC294640Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). | Drug | Opaganib |
| PlaceboStudy participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). | Drug | Placebo |
Primary outcome
Supplemental Oxygen Requirement
Time frame: 14 days maintained up to 42 days
To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.
9 secondary outcomes
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42
Time frame: 14 days maintained up to 42 days
Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0
Time frame: 14 days maintained up to 42 days
Number of Participants With Low Oxygen Flow Via Nasal Cannula
Time frame: 14 days maintained up to 42 days
Time to Discharge From Hospital Measured at 14 Days
Time frame: 14 days
Patients Requiring Intubation and Mechanical Ventilation by Day 42
Time frame: 42 days
Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14
Time frame: 14 days
Patients With Negative Swabs for SARS-CoV-2 at Day 14
Time frame: 14 days
Mortality Due to Any Cause
Time frame: 28 days
Mortality Due to Any Cause
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 Levitt, MD study director
RedHill Biopharma Limited
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Opaganib in people with COVID-19 and Lung Infection, run by RedHill Biopharma Limited at 57 sites in 10 countries.
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 5 inclusion and 21 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Russia, Brazil, Israel, Poland, Colombia and 5 more countries. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 19 Oct 2023). 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?
Supplemental Oxygen Requirement (time frame: 14 days maintained up to 42 days). 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 31 Jul 2025.