Our Site’s Contribution to FDA-Approved Therapies Since 2015

Full trial / program name

INNO2VATE Phase 3 Program

• INNO2VATE-1: Phase 3, randomized, open-label, active-controlled study evaluating oral vadadustat versus darbepoetin alfa for correction or maintenance treatment of anemia in incident dialysis-dependent chronic kidney disease.
• INNO2VATE-2: Phase 3, randomized, open-label, active-controlled study evaluating oral vadadustat versus darbepoetin alfa for maintenance treatment of anemia in dialysis-dependent chronic kidney disease.

Trial identifiers

NCT02865850 NCT02892149

FDA milestone

FDA approval: 2024 — VAFSEO approved for anemia due to CKD in adults who have been receiving dialysis for at least three months.

Source basis

FDA Drug Trials Snapshot / FDA label; site dates from internal site records.

Full trial / program name

Tenapanor IBS-C Phase 3 Program

• Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome.
• Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome.

Trial identifiers

NCT02686138 NCT02727751

FDA milestone

FDA approval: 2019 — IBSRELA approved for IBS-C in adults.

Source basis

FDA label / approval records; site dates from internal site records.

Full trial / program name

KALM-1 / KALM-2 Hemodialysis Pruritus Program

• Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients with Moderate-to-Severe Pruritus.
• 52-Week Open-Label Extension of intravenous difelikefalin / CR845 in hemodialysis-associated CKD pruritus.

Trial identifiers

NCT03422653 NCT03636269

FDA milestone

FDA approval: 2021 — KORSUVA approved for moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis.

Source basis

FDA label; site dates from internal site records.

Full trial / program name

MANDALA / PT027 Phase 3 Asthma Program

• Long-Term, Randomized, Double-Blind, Multicenter, Parallel-Group Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older with Asthma.

Trial identifiers

NCT03769090

FDA milestone

FDA approval: 2023 — AIRSUPRA approved for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in adults with asthma.

Source basis

FDA announcement / label; site dates from internal site records.

Full trial / program name

Ceftobiprole 008 / 009 Phase 3 Program

• 008: Randomized, double-blind, multicenter study to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in acute bacterial skin and skin structure infections.
• 009: Randomized, double-blind, multicenter study to establish the safety and efficacy of ceftobiprole medocaril compared with current standard of care in Staphylococcus aureus bacteremia.

Trial identifiers

NCT03137173 NCT03138733

FDA milestone

FDA approval: 2024 — ZEVTERA approved for SAB, ABSSSI, and pediatric CABP uses.

Source basis

FDA label / announcement; site dates from internal site records.

Full trial / program name

DIAMOND Heart Failure Hyperkalemia Study

• Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel-Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor Medications for the Treatment of Heart Failure.

Trial identifiers

NCT03888066

FDA milestone

FDA approval: 2015 — VELTASSA initially approved for treatment of hyperkalemia.

Source basis

FDA label; site dates from internal site records.

Full trial / program name

Flurpiridaz F 18 Phase 3 PET MPI Study

• Phase 3, Open-Label Study of Flurpiridaz F 18 Injection for Positron Emission Tomography Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease.

Trial identifiers

NCT03354273

FDA milestone

FDA approval: 2024 — FLYRCADO approved for PET myocardial perfusion imaging in adults with known or suspected coronary artery disease.

Source basis

FDA announcement; site dates from internal site records.

Full trial / program name

CLARITY AD

• Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study with an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease.

Trial identifiers

NCT03887455

FDA milestone

FDA traditional approval: 2023 — LEQEMBI converted to traditional approval after confirmatory clinical benefit data.

Source basis

FDA announcement / ClinicalTrials.gov; site dates from internal site records.

Full trial / program name

ECOSPOR III / ECOSPOR IV

• SERES-013 / ECOSPOR IV: Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adults with Recurrent Clostridioides difficile Infection.

Trial identifiers

NCT03183128 NCT03183141

FDA milestone

FDA approval: 2023 — VOWST approved to prevent recurrence of C. difficile infection in adults after antibacterial treatment for recurrent CDI.

Source basis

FDA announcement; site dates from internal site records.

Full trial / program name

TRAILBLAZER-ALZ 2 / TRAILBLAZER-ALZ 4

• TRAILBLAZER-ALZ 2: Study of Donanemab in Participants with Early Alzheimer’s Disease.
• TRAILBLAZER-ALZ 4: Phase 3, Open-Label, Parallel-Group, Two-Arm Study to Investigate Amyloid Plaque Clearance with Donanemab Compared with Aducanumab-avwa in Participants with Early Symptomatic Alzheimer’s Disease.

Trial identifiers

NCT04437511 NCT05108922

FDA milestone

FDA approval: 2024 — KISUNLA approved for Alzheimer’s disease; treatment initiation is in patients with mild cognitive impairment or mild dementia stage.

Source basis

FDA announcement; site dates from internal site records.

Full trial / program name

C3671013 / RENOIR

• Evaluation of the Efficacy and Safety of a Pre-Fusion Based RSV Vaccine in Adults 60 Years of Age and Older Compared to Placebo.

Trial identifiers

NCT05035212

FDA milestone

FDA approval: 2023 — ABRYSVO approved for prevention of RSV lower respiratory tract disease in older adults, with additional FDA-listed indications.

Source basis

FDA ABRYSVO page / Pfizer announcement; site dates from internal site records.

Full trial / program name

NN9931-4553 / ESSENCE

• ESSENCE: Phase 3 semaglutide study in nonalcoholic steatohepatitis / metabolic dysfunction-associated steatohepatitis.

Trial identifiers

NCT04822181

FDA milestone

FDA approval: 2025 — WEGOVY approved under accelerated approval for noncirrhotic MASH with moderate-to-advanced liver fibrosis.

Source basis

FDA announcement / label; site dates from internal site records.

Full trial / program name

AXS-05 Alzheimer’s Disease Agitation Program

• AXS-05-AD-302: Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer’s Type.
• AXS-05-AD-303: Long-Term Safety and Efficacy Study of AXS-05 in Subjects with Dementia of the Alzheimer’s Type.
• AXS-05-AD-304 / ADVANCE-2: Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer’s Disease Agitation.

Trial identifiers

NCT04797715 NCT04947553 NCT05557409

FDA milestone

FDA expanded approval: 2026 — AUVELITY approved for agitation associated with dementia due to Alzheimer’s disease in adults.

Source basis

FDA announcement / label; site dates from internal site records.