Sanofi clinical trial failures

Review 110 stopped clinical trials from Sanofi, 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: 17 of these records are likely biological failure signals, while the rest may reflect operational, strategic, regulatory, funding, enrollment, or unclear stop reasons.

Total stopped trials110

Likely biological signals17

Shown below100

Dominant stop reasons

OPERATIONAL: 74
OTHER/UNKNOWN: 19
EFFICACY/FUTILITY: 12
SAFETY: 5

Notable sponsors

Sanofi: 110

Related phases

Phase III: 38
Phase II: 36
Phase I: 29
Phase IV: 7

Crawlable stopped-trial records

Open Explore

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

NCT02859896: Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Phase III Secondary Hyperparathyroidism-Chronic Kidney Disease trial by Sanofi. Stop reason: OPERATIONAL.

The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.

NCT06067425: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia

Phase II Osteochondrodysplasia trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision. Not related to safety concern.

NCT06444451: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Phase II Alopecia Areata trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision; the decision is not related to any safety concern

NCT05712278: A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia

Phase I Acute Myeloid Leukaemia trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor's decision

NCT05839626: A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Phase I Relapsed/Refractory Multiple Myeloma trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on sponsor decision not driven by any safety concerns; phase 2 was not initiated.

NCT04154956: SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

Phase III Non-small Cell Lung Cancer Metastatic trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT04059484: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Phase II Breast Cancer Metastatic trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study, not linked to any safety concern.

NCT06118099: Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Phase II Hidradenitis trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision; the decision is not related to any safety concern

NCT04913220: A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

Phase I Malignant Melanoma trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT05450562: Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

Phase I Neoplasm trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT05179603: A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]

Phase II Classic Hodgkin Lymphoma trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT05086315: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Phase I Acute Lymphocytic Leukaemia trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

NCT06028230: A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Phase II Hidradenitis Suppurativa trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision. Not related to safety concern.

NCT06058156: Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Phase II Atopic Dermatitis trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision. Not related to safety concern.

NCT03284957: Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Phase I Breast Cancer trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study, not linked to any safety concern.

NCT04524689: Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC

Phase II Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT05630547: A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Phase II Multiple Sclerosis trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

The study was terminated as it did not meet its primary and key secondary endpoints

NCT04914897: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

Phase II Pleural Mesothelioma trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

NCT04659603: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

Phase II Breast Cancer Metastatic trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT03769181: A Study of Isatuximab-based Therapy in Participants With Lymphoma

Phase I Lymphoma trial by Sanofi. Stop reason: OPERATIONAL.

Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern

NCT04003818: Efficacy and Safety of Teicoplanin in CDAD

Phase IV Clostridium Difficile Infection-associated Diarrhea and Colitis trial by Sanofi. Stop reason: OPERATIONAL.

Due to COVID-19 and great challenges during patient enrolment period, current status of this study is far behind the plan. The study cannot be completed according to the plan. Sanofi decides to terminate the study upon comprehensive assessment.

NCT04333654: Hydroxychloroquine in Outpatient Adults With COVID-19

Phase I Coronavirus Infection trial by Sanofi. Stop reason: OPERATIONAL.

Rate of enrollment too slow to allow completion in a reasonable timeframe

NCT03757351: Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis

Phase I Amyotrophic Lateral Sclerosis trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Due to change in Sanofi's development strategy for DNL747/SAR443060 - not due to any safety concerns

NCT05061420: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)

Phase II Squamous Cell Carcinoma of Head and Neck trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

NCT05126329: Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function

Phase I Hepatic Function Abnormal trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study, not linked to any safety concern

NCT04191382: Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

Phase II Breast Cancer trial by Sanofi. Stop reason: OPERATIONAL.

early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT04294459: Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

Phase I Immune System Disorder trial by Sanofi. Stop reason: SAFETY.

Terminated due to non-safety reasons

NCT04705051: Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat

Phase III Congenital Cystic Kidney Disease trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

LTS15823 (long-term extension of the EFC15392 study) was stopped after protocol specified interim analysis for futility of the parent EFC15392 study met the prespecified stopping rule based on the primary outcome measure.

NCT05128773: Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

Phase III Breast Cancer trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study, not linked to any safety concern

NCT05013554: Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

Phase I Neoplasm Malignant trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT05231668: Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)

Phase I Osteogenesis Imperfecta trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT04478266: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Phase III Breast Cancer trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.

NCT03871348: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Phase I Metastatic Neoplasm trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Sponsor terminated the study for non-safety reasons

NCT05132569: Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

Phase III Myasthenia Gravis trial by Sanofi. Stop reason: OPERATIONAL.

For strategic reasons the Tolebrutinib MG study has been terminated

NCT03860844: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Phase II Acute Lymphoblastic Leukemia trial by Sanofi. Stop reason: OPERATIONAL.

Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.

NCT05552859: Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

Phase IV Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.

NCT05245071: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Phase II Non-squamous Non-small Cell Lung Cancer trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT06508489: A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies

Phase I Acute Myeloid Leukemia trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT05071053: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer

Phase II Adenocarcinoma Gastric trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT04717375: Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

Phase I Cancer trial by Sanofi. Stop reason: OPERATIONAL.

Early discontinuation based on strategic sponsor decision not driven by any safety concerns

NCT03816839: Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

Phase I Breast Cancer trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study, not linked to any safety concern.

NCT04394624: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)

Phase II Non-small Cell Lung Cancer Metastatic trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, the decision is not related to any safety concern.

NCT04418661: Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Phase I Metastatic Neoplasm trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor's decision not related to any safety concern

NCT05429762: Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

Phase I Neoplasm trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.

NCT05237284: Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Phase II Amyotrophic Lateral Sclerosis trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

The study was terminated as its Part A did not meet the primary endpoint.

NCT02187848: Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Phase I Neoplasm Malignant trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision, The decision is not related to any safety concern.

NCT04661033: Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

Phase II Warm Autoimmune Hemolytic Anemia (wAIHA) trial by Sanofi. Stop reason: OPERATIONAL.

Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.

NCT05726682: A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Phase II Allogenic Stem Cell Transplantation trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel trial, not related to safety concern.

NCT03637764: Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Phase I Neoplasm trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts.

NCT02332577: Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia

Phase IV Pneumonia trial by Sanofi. Stop reason: OPERATIONAL.

The sponsor stopped the study due to low recruitment with no safety concerns

NCT04143958: To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease

Phase IV Fabry Disease trial by Sanofi. Stop reason: OPERATIONAL.

The Sponsor terminated the study due to recruitment infeasibility without having enrolled any patient.

NCT01440179: SAR3419 in Acute Lymphoblastic Leukemia

Phase II Acute Lymphocytic Leukaemia trial by Sanofi. Stop reason: OTHER/UNKNOWN.

The study is stopped due to very modest activity compared to competitors

NCT03600818: Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Phase III Polymyalgia Rheumatica trial by Sanofi. Stop reason: OPERATIONAL.

Protracted recruitment timeline exacerbated by COVID-19 pandemic

NCT03594955: First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome

Phase I Leukaemia trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision

NCT03367819: Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Phase I Prostate Cancer trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC) cohorts.

NCT01505062: Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B

Phase I Usher Syndrome trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Study stopped not for safety reasons. Due to review of clinical development plans and priorities, Sponsor decided to stop development of the product.

NCT03761134: Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.

NCT03760965: Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.

NCT01367444: Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration

Phase I Stargardt's Disease trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Study stopped not for safety reasons. Due to review of clinical development plans and priorities, Sponsor decided to stop development of the product.

NCT03437720: Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease

Phase II Non-alcoholic Steatohepatitis trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel TRIAL, not related to safety concern.

NCT03260868: Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

Phase IV Type 1 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Due to "prolonged low participant recruitment"

NCT03434119: Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

("Trial terminated (recruitment delays)")

NCT03600805: Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Phase III Giant Cell Arteritis trial by Sanofi. Stop reason: OPERATIONAL.

Protracted recruitment timeline exacerbated by COVID-19 pandemic

NCT02497612: To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Phase II Plasmodium Falciparum Infection trial by Sanofi. Stop reason: EFFICACY/FUTILITY.

All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.

NCT03236311: A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI

Phase II Microvascular Coronary Artery Disease trial by Sanofi. Stop reason: OPERATIONAL.

(Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.)

NCT02999633: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Phase II T-cell Type Acute Leukemia-Precursor trial by Sanofi. Stop reason: OPERATIONAL.

Due to an unsatisfactory benefit/risk ratio, as specified in \& 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely

NCT03713684: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel TRIAL, not related to safety concern

NCT03770728: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel TRIAL, not related to safety concern

NCT03684642: Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel TRIAL, not related to safety concern.

NCT03496298: Effect of Efpeglenatide on Cardiovascular Outcomes

Phase III Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel TRIAL, not related to safety concern

NCT02984683: Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

Phase II Triple Negative Breast Cancer trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Study discontinued considering the limited clinical benefit combined with a higher than expected rate of known non-serious ophthalmological event.

NCT00223938: Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.

Phase IV Anemia trial by Sanofi. Stop reason: OPERATIONAL.

The study was terminated because of significant enrollment challenges

NCT02379390: Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide

Phase II Prostate Cancer Metastatic trial by Sanofi. Stop reason: OPERATIONAL.

Unsatisfactory patient accrual

NCT01217814: Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Phase II Rheumatoid Arthritis trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns

NCT00292747: Drotaverine in Dysmenorrhoea Treatment

Phase IV Dysmenorrhea trial by Sanofi. Stop reason: OPERATIONAL.

early termination due to loss of interest and low enrollment of patient

NCT01764997: An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Phase III Rheumatoid Arthritis trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Due to small number of participants entering randomization. Not a safety issue.

NCT01118728: Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Phase II Ankylosing Spondylitis trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Lack of benefit on efficacy

NCT02520102: Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia

Phase II Acute Myeloid Leukemia NOS trial by Sanofi. Stop reason: OPERATIONAL.

Company has fulfilled post-marketing requirements

NCT02667496: Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Phase II Dementia Alzheimer's Type trial by Sanofi. Stop reason: OPERATIONAL.

Slow recruitment

NCT02274740: Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Phase II Type II Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision not related to safety reasons

NCT02635243: A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia

Phase I Type 1 Diabetes Mellitus trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT00807170: Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases

Phase I Non-small Cell Lung Cancer (NSCLC) trial by Sanofi. Stop reason: OPERATIONAL.

Very slow recruitment

NCT01659138: Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis

Phase II Ulcerative Colitis trial by Sanofi. Stop reason: OPERATIONAL.

Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.

NCT01861249: Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Phase II Ulcerative Colitis trial by Sanofi. Stop reason: OPERATIONAL.

Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.

NCT00478972: Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise

Phase III Obesity trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

NCT00574275: Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

Phase III Pancreatic Neoplasm trial by Sanofi. Stop reason: SAFETY.

Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival

NCT00478595: Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

Phase III Obesity trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

NCT02331810: Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Phase I Systemic Lupus Erythematosus trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT00464061: Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

Phase III Sleep Initiation and Maintenance Disorders trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems

NCT00602745: S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

Phase III Pancreatic Neoplasm trial by Sanofi. Stop reason: OTHER/UNKNOWN.

Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical

NCT00728091: A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia

Phase III Hyponatremia trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT00359437: Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Phase III Ascites trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT00263042: Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Phase III Cardiovascular Disease trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

NCT00228176: Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant

Phase III Carotid Artery Plaque trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

NCT00576667: An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

Phase III Fatty Liver trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

NCT00439634: Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia

Phase II Schizophrenia trial by Sanofi. Stop reason: SAFETY.

Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy

NCT00690456: Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

Phase III Diabetes Mellitus, Type 2 trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

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Phase III Fatty Liver trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities

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Phase III Ascites trial by Sanofi. Stop reason: SAFETY.

Study was terminated due to safety reason.

NCT00325650: Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

Phase III Prediabetic State trial by Sanofi. Stop reason: OPERATIONAL.

Company decision taken in light of demands by certain national health authorities