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Ataciguat

Phase 2

Intermittent Claudication | Small molecule | Cardiovascular |Sanofi|Trials Updated: May 17, 2018

Ataciguat development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2001

Ataciguat target and mechanism

Molecular targetGUCY1B1, GUCY1A2, GUCY1A1
Target classActivator
ModalitySmall molecule

Also known as ataciguat (HMR1766), HMR1766

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment659

FDA Designations

No designations recorded

Ataciguat clinical trials

Ataciguat · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT00799656Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic PainPain
COMPLETED62 Analytics
NCT00443287Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial DiseaseIntermittent Claudication
COMPLETED553 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
PainUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
Intermittent ClaudicationUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in average daily pain intensity
after 28-days treatment
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
26 weeks
Number of patients experiencing orthostatic hypotension
Baseline - 14 days

The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern.

The change in blood pressure following the transition from sitting to standing
Baseline - 14 days

The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Transitioning from sitting to standing is a functional test that will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a relevant orthostatic stress.

The change in blood pressure following progressive head-up tilt
Baseline - 14 days

The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Tilt table testing will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a tightly controlled orthostatic stress.

Subject self-reports of light-headedness/orthostatic intolerance during the standing test and the head-up tilt testing
Baseline - 14 days

The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Evaluating subject perceptions of light-headedness/orthostatic intolerance will help us to understand the relationship between changes in blood pressure and changes in symptoms in this patient population before and after treatment with Ataciguat.

Secondary Endpoints

Responder rate
after 28-days treatment
Rescue medication intake
during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)
after 28-days treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFirst period: Ataciguat - Second period: Placebo
2EXPERIMENTALFirst period: Placebo - Second period: Ataciguat
3EXPERIMENTALdose level 2
4EXPERIMENTALdose level 3
5ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATORPlacebo gel capsule, dosage matches number of Ataciguat capsules for each respective dose, capsules taken once daily with breakfast for 14 consecutive days.
AtaciguatACTIVE_COMPARATORAtaciguat, orally administered gel capsule, 50, 100, or 200 mg, once per day with breakfast for 14 consecutive days

Interventions

NameTypeDescription
ataciguat (HMR1766)DRUGoral administration 200mg once daily for 28 days
placeboDRUGoral administration once daily for 28 days
cilostazolDRUGoral administration
AtaciguatDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months. Exclusion Criteria: * Presence or history of cancer within the past five years * Patients with a history of HIV infecti...

Countries:AustriaCzechiaRomaniaUnited StatesCanadaFrancePolandRussiaSouth Africa
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Frequently asked questions about Ataciguat

What is Ataciguat used for?

Ataciguat has been studied in aortic valve stenosis, intermittent claudication, and pain. It is an investigational small molecule developed by Sanofi (ticker: SNY) and has not been approved for any indication. Clinical research has explored its use in cardiovascular and pain conditions.

What does Ataciguat target?

Ataciguat targets the soluble guanylate cyclase subunits GUCY1B1, GUCY1A2, and GUCY1A1. It acts as an activator of these enzymes, which are involved in the nitric oxide signaling pathway that regulates vascular tone and blood flow.

Who is developing Ataciguat?

Ataciguat is being developed by Sanofi, a global pharmaceutical company traded under the ticker SNY. Sanofi has sponsored clinical trials of ataciguat in cardiovascular and pain indications.

What phase is Ataciguat in?

Ataciguat is in Phase 1 of clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial focused on safety in patients with moderate calcific aortic valve stenosis.

What clinical trials is Ataciguat in?

Ataciguat has been evaluated in three completed clinical trials: NCT02049203 in aortic valve stenosis, NCT00799656 in neuropathic pain, and NCT00443287 in intermittent claudication. All trials are completed, and no active trials are currently listed.

Is Ataciguat the same as HMR1766?

Yes, ataciguat is also known as HMR1766. HMR1766 was the early development code used by Sanofi, and the compound is now referred to as ataciguat in scientific literature and clinical trial records.