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Novartis Pharmaceuticals clinical trial failures

Review 366 stopped clinical trials from Novartis Pharmaceuticals, including disease areas, phases, and classified stop reasons.

This page groups real ClinicalTrials.gov-derived stopped trial records. The strongest added signal is the stop-reason classification: 46 of these records are likely biological failure signals, while the rest may reflect operational, strategic, regulatory, funding, enrollment, or unclear stop reasons.

Total stopped trials366
Likely biological signals46
Shown below100

Dominant stop reasons

OPERATIONAL
168
OTHER/UNKNOWN
150
EFFICACY/FUTILITY
34
SAFETY
12
REGULATORY
2

Notable sponsors

Novartis Pharmaceuticals
366

Related phases

Phase II
161
Phase I
95
Phase III
78
Phase IV
30
Early Phase I
2

Crawlable stopped-trial records

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Showing up to 100 representative records from this slice. Each link opens the trial detail page with source attribution and stop-reason context.

NCT03631199: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Phase III Non-small Cell Lung Cancer trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns

NCT03946670: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

Phase II Myelodysplastic Syndromes trial by Novartis Pharmaceuticals. Stop reason: EFFICACY/FUTILITY.

In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.

NCT04266301: Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Phase III Myelodysplastic Syndromes trial by Novartis Pharmaceuticals. Stop reason: EFFICACY/FUTILITY.

In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.

NCT04390763: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Phase II Metastatic Pancreatic Ductal Adenocarcinoma trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.

NCT05429502: Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Phase I Neuroblastoma trial by Novartis Pharmaceuticals. Stop reason: SAFETY.

Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.

NCT05111249: A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease

Phase II Early Manifest Huntington Disease trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

The trial was halted prematurely due to signs and symptoms that suggested the possibility of peripheral neuropathy. All participants who received branaplam continued to undergo routine (safety) evaluations for up to a year following their final dose

NCT04899349: Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

Phase II Breast Cancer trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns

NCT03447769: Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Phase III Non-Small Cell Lung Cancer trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.

NCT05024058: Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

Phase III Chronic Inducible Urticaria trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.