6 completed, 4 terminated, 1 no longer available, 1 withdrawn. 5 Not applicable, 3 Phase 2, 3 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 5 | Terminated 3, Completed 2 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 3 | Completed 1, Terminated 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
Follow APR Applied Pharma Research s.a.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution - Bioequivalence | Phase 1 | Completed | APR Applied Pharma Research s.a. | 42 | 2025-08-20 | 2026-04-28 |
| Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects RLF-OD032, Kuvan - Bioavailability | Phase 1 | Completed | APR Applied Pharma Research s.a. | 16 | 2024-07-30 | 2025-06-12 |
| Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU. PKU GOLIKE, Standard of Care - Phenylketonurias | Not applicable | Terminated | APR Applied Pharma Research s.a. | 21 | 2023-10-30 | 2026-03-11 |
| Evaluation of Phe Fluctuation in PKU Pts Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute. PKU GOLIKE - Phenylketonurias | Not applicable | Completed | APR Applied Pharma Research s.a. | 16 | 2023-06-30 | 2026-02-23 |
| Study on Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections (ARI) Sentinox - Healthy Volunteers | Not applicable | Terminated | APR Applied Pharma Research s.a. | 144 | 2022-11-07 | 2023-11-24 |
| Study to Evaluate the Effect on Nitrogen Retention of Two Different Posology Schemes of PKU GOLIKE PLUS 3-16 and Free AAs in Patients With Phenylketonuria GOLIKE PLUS 3-16, Free AAs - Phenylketonurias | Not applicable | Terminated | APR Applied Pharma Research s.a. | 5 | 2022-05-06 | 2023-07-07 |
| Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19 ZYESAMI™ (aviptadil acetate), Placebo, Nebulized administration of ZYESAMI™ or Placebo - SARS-CoV 2, COVID | Phase 3 | Withdrawn | APR Applied Pharma Research s.a. | 2021-12-15 | 2026-05-14 | |
| Study on the Performance and Safety of Sentinox in COVID-19 Patients Sentinox--Group A, Sentinox--Group B - COVID-19 (SARS-CoV-2 Infection) | Not applicable | Completed | APR Applied Pharma Research s.a. | 57 | 2021-05-20 | 2022-07-27 |
| Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 ZYESAMI™ (aviptadil acetate), Placebo, Nebulized administration of ZYESAMI™ or Placebo - SARS-CoV 2, COVID | Phase 2 / Phase 3 | Terminated | APR Applied Pharma Research s.a. | 144 | 2021-02-15 | 2023-02-03 |
| Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure Aviptadil by intravenous infusion + standard of care, Normal Saline Infusion + standard of care - Critical COVID-19 With Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS) | Phase 2 / Phase 3 | Completed | APR Applied Pharma Research s.a. | 203 | 2020-05-15 | 2023-07-24 |
| A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee Ketoprofen Topical Patch 20% - Tendonitis of the Shoulder, Elbow, or Knee | Phase 2 | Completed | APR Applied Pharma Research s.a. | 17 | 2007-06-01 | 2020-02-18 |
| ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) ZYESAMI (aviptadil acetate) - Critical COVID-19 With Respiratory Failure | No longer available | APR Applied Pharma Research s.a. | 2023-02-03 |
Acute Lung Injury (3) · Phenylketonurias (3) · Respiratory Distress Syndrome (3) · COVID-19 (2) · Dyspnea (2) · Acute Pain (1) · Coronavirus Infections (1) · Respiratory Insufficiency (1)
aviptadil (4) · Standard of Care (2) · sapropterin (2) · Powders (1) · Solutions (1) · Suspensions (1) · Vasoactive Intestinal Peptide (1)
Italy (4) · United States (4) · Canada (2) · United Kingdom (1)
Jonathan C Javitt, MD, MPH (4) · Anita MacDonald, Pr. (1) · Giuseppe Banderali (1) · Mark L. Freedman, MD,FRCPC (1) · Valentina Rovelli, MD (1)