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Ramipril

Phase 4FDA approved

Glomerulonephritis | Small molecule | Nephrology |Sanofi|Trials Updated: Apr 25, 2022

Ramipril development status

FDA approval on record Feb 27, 2007 as Altace
Approval holderKing Pfizer
ApplicationNDA022021
Highest phase Phase 4 (NCT00841880)
Phase scored for SNYPhase 3
Registered trials 30 across 13 sponsors since Aug 2002

Ramipril target and mechanism

Molecular targetACE
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials3
Total Enrollment76

FDA Designations

No designations recorded

Ramipril clinical trials

Ramipril · 3 trials · 4 indications

Phase 3 2Phase 1 1
NCT00437463Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) InhibitorGlomerulonephritis
COMPLETED60 Analytics
NCT00268619FOCUS:Focus On Coronary Unstable SyndromesMyocardial Ischemia
COMPLETED- Analytics
PHASE3COMPLETED
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
GlomerulonephritisUnlock trial analytics
PHASE3COMPLETED
FOCUS:Focus On Coronary Unstable Syndromes
Myocardial IschemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
From the beginning to the end of the study
Development of proteinuria
From the beginning to the end of the study
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
From the beginning to the end of the study
body weight, blood pressure, pulse
From the beginning to the end of the study
Adverse effects of treatment
From the beginning to the end of the study
To assess the highly specific C-reactive protein (hsCRP) blood levels
during the study conduct
To assess the tumor necrosing factor alpha (TNFα) blood levels
during the study conduct
Assessment of PK parameter: AUCtau
On Day 10 (Period 2)

Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)

Secondary Endpoints

TEAEs collection
From the signature of the informed consent up to the end of the study
Assessment of PK parameter: Cmax
On Day 10 (Period 2)
Assessment of PK parameter: tmax
On Day 10 (Period 2)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRamipril
2NO_INTERVENTION -
SAR439954 with or without ramiprilEXPERIMENTAL* On Period 1, following an overnight fast, subjects will receive once daily single morning oral intake of sotagliflozin from Day 1 to Day 5 followed by the first meal that has to be started within 10 min after dosing. * On Day 1 of the Period 2, study subjects will begin a 10-day ramipril regimen following an overnight fast. From Day 6 to Day 10, subjects will receive once daily single morning oral intake of ramipril concomitantly to the sotagliflozin dosing.

Interventions

NameTypeDescription
RamiprilDRUG2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
Sotagliflozin (SAR439954)DRUGPharmaceutical form: tablets Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * biopsy-confirmed IgA nephropathy * proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l Exclusion Criteria: * pregnant or nursing mother, or women of childbearing potential without an effective method of birth control * history of...

Countries:Hong KongGermany
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Competitive Landscape -Membranoproliferative Glomerulonephritis 2 trials (matched to "Glomerulonephritis")

CompanyTickerTrialsLead PhaseDrugs
Apellis Pharmaceuticals, Inc.APLS2PHASE3Pegcetacoplan
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Frequently asked questions about Ramipril

What is Ramipril?

Ramipril is a small molecule ACE inhibitor developed by Sanofi. It is being studied in diabetes mellitus, glomerulonephritis, and myocardial ischemia. Ramipril is an investigational therapy in clinical development rather than a newly approved product, and it has been evaluated in completed Phase 1 and Phase 3 trials.

What does Ramipril target?

Ramipril targets ACE, or angiotensin-converting enzyme, and acts as an inhibitor of that target. By inhibiting ACE, Ramipril belongs to the ACE inhibitor class of small molecule agents. This mechanism underlies its evaluation across metabolic and cardiovascular indications including diabetes mellitus, glomerulonephritis, and myocardial ischemia.

Who makes Ramipril?

Ramipril is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for Ramipril across its studied indications, including diabetes mellitus, glomerulonephritis, and myocardial ischemia.

What phase is Ramipril in?

Ramipril has been studied in Phase 1 and Phase 3 clinical trials, all of which are completed. It is an investigational agent in clinical development. The program includes one Phase 1 drug-drug interaction study and two Phase 3 studies, with no active trials currently listed.

What clinical trials is Ramipril in?

Ramipril has been evaluated in completed trials including NCT03414723, a Phase 1 drug-drug interaction study with sotagliflozin in diabetes mellitus and healthy subjects in Germany; NCT00437463, a Phase 3 study in IgA nephropathy and glomerulonephritis in Hong Kong; and NCT00268619, the Phase 3 FOCUS study in myocardial ischemia.