Drugs / Cuvitru
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05764993 | Jun 2023 → Feb 2025 | chronic obstructive pulmonary disease | Rochester General Hospital | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03814798 | Dec 2019 → Sep 2020 | immunodeficiency disease | Grifols Therapeutics LLC | Withdrawn | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03737617 | Aug 2022 → Aug 2024 | bronchiectasis, selective IgG subclass deficiency | University of Edinburgh | Withdrawn | No outcome recorded |
| Phase 4 | NCT04566692 | Nov 2020 → Jul 2022 | immunodeficiency disease | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 4 | NCT03116347 | May 2017 → Jan 2021 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-25 | Takeda | Takeda Announces Approval of CUVITRU Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗ |
| 2017-03-06 | Takeda | CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Data Demonstrate Improved Treatment Satisfaction Relative to Patients’ Previous Immunoglobulin Therapy takeda.com ↗ |
| 2016-11-16 | Takeda | Shire launches CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in the U.S. for Primary Immunodeficiency takeda.com ↗ |
| 2016-11-12 | Takeda | Tolerability Data for Shire’s Cuvitru Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting takeda.com ↗ |
| 2016-09-14 | Takeda | Shire announces U.S. FDA approval of CUVITRU™ [immune globulin subcutaneous (human), 20% solution] treatment for Primary Immunodeficiency takeda.com ↗ |
| 2016-06-10 | Takeda | Shire announces completion of decentralized procedure in Europe for Immunoglobulin Treatment Cuvitru takeda.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cuvitru | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03116347 ↗ |
| Known as | IGSC 20% | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03814798 ↗ |
| Modality | Protein / enzyme biologic | “200 mg/ml solution for Immune Globulin Subcutaneous Injection” NCT03116347 ↗ |
| Route | Subcutaneous | “200 mg/ml solution for Immune Globulin Subcutaneous Injection” NCT03116347 ↗ |