Drugs / NXT007
last change May 2026 re-read 9 days ago

NXT007

Developed for
hemophilia A
Investigated by
Hoffmann-La Roche · Chugai Pharmaceutical

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06189508 Feb → Dec 2024 — Hoffmann-La Roche Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05987449 Sep 2023 → Dec 2033 expected hemophilia A Hoffmann-La Roche Recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT07838194 Nov 2026 → Sep 2028 expected hemophilia A Hoffmann-La Roche Not yet recruiting No outcome recorded
Phase 3 NCT07416526 May 2026 → Sep 2027 expected hemophilia A Hoffmann-La Roche Recruiting No outcome recorded
Phase 3 NCT07416604 Apr 2026 → Feb 2028 expected hemophilia A Hoffmann-La Roche Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2026-02-09 Chugai Pharmaceutical Results NXT007 Suggests Favorable Tolerability and Efficacy in Phase I/II Study for Hemophilia A Following Direct Switch from Emicizumab without Washout Period chugai-pharm.co.jp ↗
Similar to Part B in emicizumab-naïve participants, the highest-dose cohorts achieved plasma concentrations expected to provide factor VIII activity within the normal range, with no bleeds requiring treatment
2025-11-03 Hoffmann-La Roche Results Roche to present new data from its broad and innovative haematology portfolio at ASH 2025 roche.com ↗
Positive phase I/II results, including new data from a global study in people with haemophilia A with and without factor VIII inhibitors, suggest the potential of Roche’s next-generation investigational bispecific antibody to normalise haemostasis.
2025-11-03 Genentech, Inc. Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗
Positive Phase I/II results, including new data from a global study in people with hemophilia A with and without factor VIII inhibitors, suggest the potential of Genentech’s next-generation investigational bispecific antibody to normalize hemostasis.
2025-06-23 Hoffmann-La Roche Results Early data suggest Roche’s NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A roche.com ↗
In presented data from the primary analysis, no treated bleeds were observed with NXT007 in the highest dose cohorts (B-3 and B-4).
2025-06-23 Chugai Pharmaceutical Results Phase I/II Study in Hemophilia A Suggests NXT007 May Have the Potential to Provide Hemostatic Normalization chugai-pharm.co.jp ↗
We are very excited that this first data in people with hemophilia A, suggests that NXT007 has the potential to provide hemostatic normalization.
2023-11-07 Chugai Pharmaceutical Results Non-Clinical Research Results of Chugai’s NXT007 Published in Journal of Thrombosis and Haemostasis chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the results of non-clinical research on NXT007, have been published in the online version of the Journal of Thrombosis and Haemostasis (JTH).

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as NXT007 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05987449 ↗
4

NCT06189508 ↗

NCT07416526 ↗

NCT07416604 ↗

NCT07838194 ↗

Route Subcutaneous “NXT007 administered subcutaneously (SC)” NCT05987449 ↗