Drugs / NISEVOKITUG
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05417386 | Aug 2022 → Jul 2023 | pancreatic adenocarcinoma | Colin D. Weekes, M.D., PhD | Terminated | No outcome recorded |
| Phase 1 | NCT04810611 | Jun 2021 → Apr 2024 | myelodysplastic syndrome | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04283526 | Nov 2020 → Apr 2024 | myelofibrosis, primary myelofibrosis | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02947165 | Apr 2017 → Jun 2021 | breast cancer, colorectal cancer, hepatocellular carcinoma, kidney cancer +2 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04097821 | Sep 2019 → May 2023 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT05546411 | Jan → Aug 2023 | pancreatic adenocarcinoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT04952753 | Nov 2021 → Jan 2025 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04390763 | Oct 2020 → Apr 2024 | pancreatic ductal adenocarcinoma | Novartis Pharmaceuticals | Terminated | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT04935359 | Sep 2021 → Aug 2024 | pancreatic ductal adenocarcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-07-28 | XOMA (US) LLC | Regulatory U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793 xoma.com ↗
XOMA Corporation (NASDAQ: XOMA), announced today NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. Food and Drug Administration. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-07-28 | XOMA (US) LLC | U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793 xoma.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NISEVOKITUG | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298057 ↗ |
| Known as | NIS793 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04810611 ↗ |
| Action | Inhibit | “proof of mechanism of NIS793 is supported by evidence of target engagement and TGF-β pathway inhibition.” PMID 38030303 ↗ Nov 2023 |
| Modality | Monoclonal antibody | “NIS793 is a human IgG2 monoclonal antibody” PMID 38030303 ↗ Nov 2023 |
| Route | Intravenous | “700 mg/7 mL concentrate for infusion for intravenous use” NCT04097821 ↗ |