Drugs / ADVATE
ADVATE
also known as
BAY 81-8973 · Kogenate FS · Recombinant Factor VIII · BAY14-2222 · octocog-alfa · Antihemophilic Factor (Recombinant) · rFVIII · Kogenate · +17 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kogenate Bayer | — | 2000-08-04 | europa.eu ↗ |
Trials 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT05042440 | Aug → Nov 2021 | hemophilia A | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04864743 | Jun → Oct 2021 | severe hemophilia A | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05251090 | Jun → Nov 2021 | hemophilia A | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02716194 | Mar 2016 → Jan 2017 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 1 | NCT02483208 | Jun → Jul 2015 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01653639 | Jul → Dec 2012 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01599819 | Sep 2011 → Jul 2012 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 1 | NCT01184820 | Oct 2010 → Oct 2011 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00837356 | Mar → Oct 2009 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00629837 | Sep 2005 → Mar 2006 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03205163 | Aug 2017 → Nov 2018 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02586012 | Sep 2015 → Jan 2020 | hemophilia | Craig Seaman | Terminated | No outcome recorded |
| Phase 2 | NCT00717626 | Jul 2008 → Apr 2011 | hemophilia A | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT01736475 | Jan 2013 → Jul 2014 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT01486927 | Feb 2012 → Dec 2014 | hemophilia A | CSL Behring | Completed | No outcome recorded |
| Phase 2/3 | NCT00157040 | Jun 2002 → Jan 2005 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT00157053 | Nov 2001 → Aug 2004 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT02932618 | Nov 2017 → Apr 2026 | von Willebrand disease (hereditary or acquired) | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT02930317 | Aug 2016 → Oct 2017 | hemophilia A | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02306694 | Dec 2014 → Apr 2018 | bone disorder, hemophilia | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 3 | NCT02210091 | Oct 2014 → Oct 2015 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01405742 | Jul 2012 → Nov 2013 | severe hemophilia A | University of Pittsburgh | Terminated | No outcome recorded |
| Phase 3 | NCT01410227 | Nov 2011 → Feb 2014 | hereditary von Willebrand disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01376700 | Aug 2011 → Nov 2012 | hemophilia A | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01311648 | Jun 2011 → Sep 2019 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01233258 | Jan 2011 → Dec 2012 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01181128 | Nov 2010 → Aug 2012 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01125813 | Jun 2010 → Jan 2012 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01029340 | Dec 2009 → Jun 2012 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00623480 | Mar 2008 → Sep 2011 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00606060 | Jul 2004 → May 2005 | hemophilia | Bayer | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06864975 | Mar 2025 → Mar 2028 expected | hemophilia A | Runhui WU | Recruiting | No outcome recorded |
| Phase 4 | NCT04985682 | Jan 2022 → Feb 2023 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT04565236 | Sep 2020 → Mar 2024 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02170402 | Jun 2014 → May 2016 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT02314325 | Apr 2014 → May 2016 | severe hemophilia A | St. James's Hospital, Ireland | Unknown | No outcome recorded |
| Phase 4 | NCT01810666 | Mar 2013 → Jan 2014 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00632814 | Jun 2007 → Sep 2009 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00621673 | May → Oct 2006 | hemophilia A | Bayer | Terminated | No outcome recorded |
| Phase 4 | NCT00289536 | Feb 2006 → Apr 2007 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00586521 | Feb 2006 → Mar 2008 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00243386 | Jan 2006 → Jun 2010 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT01085344 | Jun 1997 → Dec 2012 | severe hemophilia A | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02282410 | Dec 2014 → Dec 2016 | hemophilia A | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00989196 Comparator | May 2010 → Oct 2011 | hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07129343 Background | Oct 2025 → Nov 2027 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05582993 Background | Nov 2024 → Apr 2030 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT03879135 Background | Apr 2019 → Jan 2025 | von Willebrand disease (hereditary or acquired) | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT02973087 Background | Nov 2017 → Jul 2020 | von Willebrand disease (hereditary or acquired) | Takeda | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT00916032 Comparator | Jun 2009 → Apr 2010 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00666406 Comparator | Mar 2008 → Feb 2009 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01051544 Comparator | Sep 2009 → Jun 2020 | severe hemophilia A | City of Hope Medical Center | Withdrawn | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-03-05 | Takeda | Shire launches myPKFiT™ for ADVATE® [Antihemophilic Factor (Recombinant)] in the U.S. takeda.com ↗ |
| 2017-12-19 | Takeda | Shire receives FDA clearance for myPKFiT™ for Advate® [Antihemophilic Factor (Recombinant)] to help personalize care for hemophilia A takeda.com ↗ |
| 2016-06-20 | CSL Behring | AFSTYLA® – CSL Behring’s Novel Recombinant Factor VIII Single Chain Therapy for Hemophilia A – Now Available in the U.S. csl.com ↗ |
| 2016-05-26 | CSL Behring | 20 U.S. FDA Approves CSL Behring’s AFSTYLA®-- The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A csl.com ↗ |
| 2014-05-01 | CSL Behring | CSL Behring Enrolls First Patient in Global Pediatric Phase III Pivotal Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) to Treat Severe Hemophilia A csl.com ↗ |
| 2009-09-21 | CSL Behring | Helixate FS from CSL Behring Now Available in 3000 IU Dosage Strength to Improve Patient Convenience csl.com ↗ |
| 2009-08-17 | CSL Behring | Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A csl.com ↗ |
Evidence & citations 29 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADVATE | “OBJECTIVES: To compare the efficacy of two prophylaxis regimens (primary outcome) and of on-demand and prophylaxis treatments (secondary outcome), and to continue the...” PMID 22212248 ↗ Mar 201220“OBJECTIVE: To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine...” PMID 19216617 ↗ Mar 2009 “A phase 1 study compared the pharmacokinetic (PK) profile of BAX 855 with that of licensed rFVIII (Advate).” PMID 26157075 ↗ Jul 2015 “A phase 1 study compared the pharmacokinetic (PK) profile of BAX 855 with that of licensed rFVIII (Advate).” PMID 26157075 ↗ Jul 2015 “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗ “Weekly infusions of ADVATE.” NCT01376700 ↗ “Advate” NCT01051544 ↗ |
| Known as | Antihemophilic Factor (Recombinant) | “ADVATE [Antihemophilic Factor (Recombinant)]” NCT02314325 ↗ |
| Known as | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | “OBJECTIVES: To compare the efficacy of two prophylaxis regimens (primary outcome) and of on-demand and prophylaxis treatments (secondary outcome), and to continue the...” PMID 22212248 ↗ Mar 2012 |
| Known as | Antihemophilic factor, recombinant, manufactured protein-free | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00289536 ↗ |
| Known as | BAY 81-8973 | “BAY 81-8973 (octocog alfa; Kovaltry®) is an unmodified, full-length recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate® FS, but produced...” PMID 27577234 ↗ Oct 20168“BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize...” PMID 25546368 ↗ Mar 2015 “BAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A.” PMID 28005225 ↗ Sep 2017 “BAY 81-8973 (Kovaltry(®) ) is a full-length, unmodified recombinant human factor VIII (FVIII)” PMID 27339736 ↗ Jun 2016 “Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1” NCT04565236 ↗ “Biological: Recombinant Factor VIII (Kovaltry, BAY81-8973)” NCT01311648 ↗ |
| Known as | BAY14-2222 | “one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg” NCT01029340 ↗7“BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01184820 ↗ “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00623480 ↗ “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01810666 ↗ “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01653639 ↗ “Kogenate (BAY 14-2222)” NCT00621673 ↗ “Kogenate (BAY14-2222)” NCT00606060 ↗ |
| Known as | Beriate P | “Beriate P” NCT01051544 ↗ |
| Known as | FVIII | “Using FVIII (Advate) 50IU/kg.QoD or 100IU/kg.QoD” NCT06864975 ↗ |
| Known as | Helixate | “Helixate” NCT01051544 ↗ |
| Known as | Helixate FS | “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗ |
| Known as | KoegenateFS | “Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)” NCT01085344 ↗ |
| Known as | Kogenate | “Kogenate” NCT01051544 ↗ |
| Known as | Kogenate FS | “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00623480 ↗8“Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01810666 ↗ “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00629837 ↗ “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT01653639 ↗ “rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Known as | Kogenate SF | “Kogenate SF” NCT01051544 ↗ |
| Known as | Kovaltry | “BAY 81-8973 (Kovaltry(®) ) is a full-length, unmodified recombinant human factor VIII (FVIII)” PMID 27339736 ↗ Jun 2016 |
| Known as | Monarch M | “Monarch M” NCT01051544 ↗ |
| Known as | Monoclate | “Monoclate” NCT01051544 ↗ |
| Known as | octocog-alfa | “BAY 81-8973 (octocog alfa; Kovaltry®) is an unmodified, full-length recombinant factor VIII (FVIII) concentrate with the same amino acid sequence as Kogenate® FS, but produced...” PMID 27577234 ↗ Oct 20167“rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week” NCT00632814 ↗ “rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Known as | rAHF-PFM | “OBJECTIVES: To compare the efficacy of two prophylaxis regimens (primary outcome) and of on-demand and prophylaxis treatments (secondary outcome), and to continue the...” PMID 22212248 ↗ Mar 20121“OBJECTIVE: To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine...” PMID 19216617 ↗ Mar 2009 |
| Known as | Rec. factor VIII | “Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase.” NCT01810666 ↗ |
| Known as | Recombinant Factor VIII | “Recombinant Factor VIII (Kogenate FS, BAY14-2222)” NCT00629837 ↗8“recombinant factor VIII” NCT01405742 ↗ |
| Known as | Recombinant Factor VIII (rAHF) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00666406 ↗ |
| Known as | Recombinate | “Recombinate” NCT01051544 ↗ |
| Known as | Replenate | “Replenate” NCT01051544 ↗ |
| Known as | rFVIII | “Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP” NCT01233258 ↗ |
| Known as | rFVIII-FS | “rFVIII-FS (octocog-alfa), (Kogenate FS)” NCT00586521 ↗ |
| Action | Restore | “factor VIII replacement” NCT00717626 ↗ |
| Modality | Protein / enzyme biologic | “a recombinant FVIII concentrate” PMID 19216617 ↗ Mar 2009 |
| Route | Intravenous | “intravenously (IV)” NCT00623480 ↗ |