NIS793
NOVARTIS AG NVS NVSEF · Metastatic Pancreatic Ductal Adenocarcinoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
- Indication
- Metastatic Pancreatic Ductal Adenocarcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 30 Sep 20211 linked trial
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for NIS793. Editors add each one with its source.
Filed application
No filed application is on record for NIS793. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for NIS793.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04935359ClinicalTrials.gov record for NCT04935359 (opens in a new tab) | Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2 | Phase 3 | Completed | 511 (actual) | 13 Aug 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04935359 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04935359 Serious adverse events (Adverse events were collected from the first dose through the end of the extended follow-up period (end of study), up to approximately 34 months. Deaths were recorded from study start through the end of post-treatment follow-up (end of study). On-treatment adverse events (up to 30 days after the last dose) and post-treatment follow-up events are reported separately.): Safety Run-in (NIS793 + Gemcitabine/Nab-Paclitaxel): on-Treatment 13 of 21; Safety Run-in (NIS793 + Gemcitabine/Nab-Paclitaxel): Post-Treatment 2 of 18; Randomized Arm A (NIS793 + Gemcitabine/Nab-Paclitaxel): On-treatment 144 of 239; Randomized Arm A (NIS793 + Gemcitabine/Nab-Paclitaxel): Post-treatment 21 of 192; Randomized Arm B (Placebo + Gemcitabine/Nab-Paclitaxel): On-Treatment 110 of 241; Randomized Arm B (Placebo + Gemcitabine/Nab-Paclitaxel): Post-Treatment 28 of 200 Source: ClinicalTrials.gov results for NCT04935359 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as NIS793.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT04935359 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.