Simplifying Guideline-Directed

Therapy in Hypertension

Simplifying Guideline-Directed

Therapy in Hypertension

A once-daily fixed-dose combination of extended-release eplerenone and chlorthalidone

A once-daily fixed-dose combination of extended-release eplerenone and chlorthalidone

Our Approach

Our Approach

The Guidelines Are Clear

Reality Is Not

Hypertension guidelines

define clear escalation pathways

Treatment complexity

increases with each step

Adherence declines precisely when escalation is required

The failure point is predictable and fixable.

The failure point is predictable
and fixable.

Pill Burden Undermines Adherence

Each additional pill reduces persistence and control. Simplification preserves both.

Baseline Therapy

ACEi/ARB

CCB

HCTZ

Current Standard of Care

Replace HCTZ with Chlorthalidone

and add Mineralocorticoid Antagonist

ACEi/ARB

CCB

HCTZ

Chlorthalidone

Eplerenone

Eplerenone

Summarnos Solution

Replaces two separate drugs with one pill,

combines 3 pills in one

ACEi/ARB

CCB

Summarnos FDC

Chlorthalidone

Baseline Therapy

ACEi/ARB

CCB

HCTZ

ACEi/ARB

CCB

Chlorthalidone

Eplerenone

Eplerenone

Step 1

Replace HCTZ with Chlorthalidone

and add Mineralocorticoid Antagonist

ACEi/ARB

CCB

Summarnos FDC

Chlorthalidone

Step 2

Replaces two separate drugs with one pill,

combines 3 pills in one

Lower pill burden.

Simpler escalation.

Better adherence potential.

Lower pill burden.

Simpler escalation.

Better adherence potential.

Lower pill burden.

Simpler escalation.

Better adherence potential.

Summarnos FDC

A once-daily fixed-dose combination delivering guideline-mandated escalation without added complexity.

Extended-release eplerenone

Chlorthalidone

Once-daily
dosing

Reduced
pill burden
at escalation

Complementary Mechanisms

Eplerenone reduces mineralocorticoid-mediated sodium retention and fibrosis

Chlorthalidone provides sustained

natriuresis and blood pressure lowering

Guideline-Preferred Agents

Both components are recommended

for resistant or difficult-to-control hypertension

Fixed-dose combinations improve

adherence and persistence

Complementary Mechanisms

Eplerenone reduces mineralocorticoid-mediated sodium retention and fibrosis

Chlorthalidone provides sustained

natriuresis and blood pressure lowering

Guideline-Preferred Agents

Both components are recommended

for resistant or difficult-to-control hypertension

Fixed-dose combinations improve

adherence and persistence

Why Extended‑Release Eplerenone Matters?

Standard eplerenone has a 4-hour half‑life → BP variability

ER formulation provides:

Smoother 24‑hour plasma levels

Reduced

peaks/troughs

More consistent

BP control

Better

tolerability

Aligns with chlorthalidone’s long half‑life for synchronized pharmacodynamics

Extended-release (ER) eplerenone

Immediate-release (IR) eplerenone

For illustrative purposes only

Summarnos is engineered for stable,

round‑the‑clock BP control.

De-Risked Development Path

Phase 1

PK bridging

Phase 1

PK bridging

Phase 3

Contribution-of-components,

ABPM endpoint

Phase 3

Contribution-of-components,

ABPM endpoint

NDA submission

under 505(b)(2)

NDA submission

under 505(b)(2)

Capital-efficient. Regulator-aligned.

Capital-efficient.
Regulator-aligned.

Execution Timeline

Pre-IND and FDA alignment

Pre-IND and FDA alignment

IND submission

IND submission

Phase 1 & Phase 3 execution

Phase 1 & Phase 3 execution

NDA submission

(~30 months from IND)

NDA submission

(~30 months from IND)

Focused milestones.

Disciplined execution.

The Team

Vlad Bogin

MD, FACP

Co-Founder

Clinical development, CRO leadership, execution

Vlad Bogin

MD, FACP

Co-Founder

Clinical development, CRO leadership, execution

Physician-executive with 30+ years across clinical medicine, global drug development, and FDA-facing regulatory strategy.​

Founder & CEO of Cromos Pharma CRO, leading Phase 1–3 programs across multiple therapeutic areas.

Former Chairman & President of Medistem (MEDS), contributing to its successful exit.​
Deep experience in IND/NDA-enabling trials, FDA interactions, protocol design, and capital-efficient development strategies.​

Vlad Bogin

MD, FACP

Co-Founder

Clinical development, CRO leadership, execution

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Tony Chu

Co-Founder

CDMO ownership, formulation, manufacturing scale-up

Tony Chu

Co-Founder

CDMO ownership, formulation, manufacturing scale-up

Owner-operator of a CDMO with expertise in formulation development, manufacturing, and scale-up of complex drug products.

20+ years leading cross-border operations across the U.S., Europe, China, and Southeast Asia.​

Brings end-to-end CMC execution, from early formulation strategy through commercial readiness, ensuring scalable, regulatory-ready manufacturing.​

Tony Chu

Co-Founder

CDMO ownership, formulation, manufacturing scale-up

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Dennis Breen

Regulatory Advisor

FDA approvals of fixed-dose combinations in hypertension

Dennis Breen

Co-Founder

FDA approvals of fixed-dose combinations in hypertension

Senior FDA regulatory expert with 25+ years guiding programs from pre-IND through NDA approval, with deep specialization in cardiovascular and hypertension therapies.​

Lead author on 14 NDAs, responsible for integrated summaries, labeling, and FDA review responses, including complex fixed-dose combinations and expedited pathways.​

Dennis Breen

Regulatory Advisor

FDA approvals of fixed-dose combinations in hypertension

Learn More

Proven Execution Across Clinical, Manufacturing, and Regulatory.

Building a World-Class Advisory Network

Summarnos is engaging leading cardiologists and hypertension experts committed to practical, guideline-based care.

info@summarnos.bio

For partnership and collaboration inquiries, please contact our team via email. We will be pleased to review your request and provide further information as needed.

Expertise that shapes execution.

Expertise that
shapes execution.

© Summarnos Pharmaceuticals. All rights reserved.

© Summarnos Pharmaceuticals. All rights reserved.