Drugs / HYQVIA
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | HyQvia | — | 2013-05-16 | europa.eu ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06895967 | Mar → Jul 2025 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04578535 | Oct 2020 → Mar 2022 | — | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02556437 | Jun 2016 → May 2018 | multifocal motor neuropathy | Johannes Jakobsen | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05755035 | Oct 2023 → Jan 2026 | immunodeficiency disease | Takeda | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06747351 | May 2025 → Jun 2028 expected | chronic inflammatory demyelinating polyradiculoneuropathy | Takeda | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03116347 | May 2017 → Jan 2021 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT02881437 | Nov 2016 → Mar 2018 | immunodeficiency disease | University Hospital, Lille | Completed | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-21 | Takeda | Takeda Receives FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices to Simplify HYQVIA® Administration takeda.com ↗ |
| 2024-12-27 | Takeda | Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗ |
| 2024-06-18 | Takeda | Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting takeda.com ↗ |
| 2024-01-29 | Takeda | Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 2024-01-16 | Takeda | U.S. FDA Approves Takeda’s HYQVIA ® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 2023-12-15 | Takeda | Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 2022-07-21 | Takeda | Takeda Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating HYQVIA ® for Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) takeda.com ↗ |
| 2016-07-21 | Takeda | Shire launches pediatric indication for immunodeficiency treatment HyQvia in Europe takeda.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HyQvia | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02556437 ↗ |
| Known as | IgHy10 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02881437 ↗ |
| Modality | Protein / enzyme biologic | “Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection” NCT02556437 ↗ |
| Route | Subcutaneous | “Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection” NCT02556437 ↗ |