Side-by-side · Research reference

ACE-031vsCardiogen

Side-by-side comparison across mechanism, dosage, evidence, side effects, administration, and stack synergies. Citations on every claim where available.

APhase 2HUMAN-REVIEWED10/44 cited

BAnimal-MechanisticHUMAN-REVIEWED5/46 cited

ACE-031

ActRIIB-Fc Fusion · Phase 2 Halted

Phase 2Highest trial stage

2011Development halted

~58.4 kDaMolecular weightReichel 2025

SQ · Weekly dosing investigated

Cardiogen

Bioregulator · Cardiac

CardiacTissue target

Gene regulationMechanism

AnimalEvidence level

SQ · Variable protocols

01Mechanism of Action

Parameter

ACE-031

Cardiogen

Primary target

Myostatin, GDF11, activin A — TGF-β superfamily ligands

Cardiovascular cell gene expressionKhavinson 2022

Pathway

Soluble decoy receptor binds circulating myostatin/TGF-β ligands → prevents ActRIIB activation → SMAD2/3 pathway inhibition

Peptide bioregulation → modulation of SASP / inflammaging → cardiac tissue homeostasisKhavinson 2022

Downstream effect

Disinhibition of myogenic signaling, increased skeletal muscle mass and strength

Suppression of senescence-associated secretory phenotype (SASP), reduction of age-related inflammatory markers, modulation of heat shock protein expression in cardiac tissue

Feedback intact?

—

Presumed — peptide bioregulators act via gene regulation, not receptor agonism

Origin

Recombinant fusion protein: human ActRIIB extracellular domain + IgG1-Fc fragmentReichel 2025

Derived from cardiac tissue peptide extracts; synthetic analogue based on Khavinson bioregulator methodology

Antibody development

—

02Dosage Protocols

Parameter

ACE-031

Cardiogen

Clinical dosing

Weekly or biweekly SQ injections (exact doses undisclosed pre-halt)

Phase 2 DMD trial protocol not fully published.

—

Black market products

Variable purity; 12/14 tested products contained target protein plus contaminantsReichel 2025

SDS-PAGE revealed multiple protein bands; quality control absent.Reichel 2025

—

Evidence basis

Phase 2 trial discontinued — incomplete dataset

Animal models / mechanistic studies

No Phase 1+ human trials in PubMed.

Half-life

Days to weeks (Fc-fusion typical kinetics)

IgG1-Fc domain confers extended circulation time.

—

Duration investigated

12–24 weeks (trial cut short)

—

Standard dose

—

Variable — typically 10–20 mg per course

No standardised human protocol; animal-derived dosing.

Frequency

—

Intermittent courses — 10–20 days, repeated periodically

Khavinson-school bioregulators typically dosed as periodic interventions, not continuous.

Route

—

Subcutaneous injection

Duration

—

10–20 day courses, repeated 2–4× per year

Russian geriatric protocols; unclear extrapolation to general populations.

04Side Effects & Safety

Parameter

ACE-031

Cardiogen

Epistaxis (nosebleeds)

Significant incidence in Phase 2 DMD trial — primary safety signal

—

Telangiectasia

Dilated capillaries / spider veins observed

—

Vascular abnormalities

Mechanism: ActRIIB/ALK1 pathway disruption affects vascular homeostasis

—

Injection site reactions

Local erythema, induration (biologics class effect)

Mild erythema, induration (presumed)

Antibody development

Potential for anti-drug antibodies (Fc-fusion proteins); incidence not reported

—

Black market contaminants

12/14 tested products contained multiple unidentified proteins alongside ACE-031Reichel 2025

—

Systemic adverse events

—

No documented serious AEs in available literature

Very limited safety data; no rigorous pharmacovigilance.

Immunogenicity

—

Unknown — no antibody development studies published

Long-term safety

—

Unknown — no extended human trials indexed in PubMed

Absolute Contraindications

ACE-031

·History of vascular disorders (epistaxis, telangiectasia, HHT)
·Pregnancy (TGF-β pathway critical for fetal development)
·Active malignancy (myostatin inhibition may affect tumour growth)
·Use of non-pharmaceutical grade ACE-031 (contamination risk)Reichel 2025

Cardiogen

·Active malignancy (theoretical peptide growth factor concern)
·Hypersensitivity to peptide components

Relative Contraindications

ACE-031

·Coagulation disorders or anticoagulant use (epistaxis risk)
·Hereditary hemorrhagic telangiectasia (HHT) family history
·Cardiovascular disease (vascular remodeling effects unknown)

Cardiogen

·Acute cardiac events (no safety data in acute MI, unstable angina)
·Pregnancy / lactation (no reproductive toxicity data)

05Administration Protocol

Parameter

ACE-031

Cardiogen

1. Pharmaceutical status

ACE-031 is not FDA-approved or commercially available. Phase 2 development was discontinued in 2011 due to safety concerns. Any ACE-031 on the black market is unregulated research chemical.

Add sterile water or saline per manufacturer instructions (typically 1–2 mL per lyophilised vial). Roll gently to dissolve.

2. Black market quality

12 of 14 tested black market ACE-031 products contained the target protein but also carried multiple unidentified protein contaminants detectable by SDS-PAGE. Two products contained no ACVR2B-immunoreactive material.Reichel 2025

Subcutaneous — abdomen or thigh. Rotate sites. Use sterile technique.

3. Detection in sport

ACE-031 is prohibited under WADA S4.3 (Myostatin Inhibitors). Gel electrophoresis and Western blotting using ACVR2B-specific antibodies can detect the ~58.4 kDa protein in biological samples.Reichel 2025

Variable — often evening injection. No established circadian preference.

4. Clinical trial route

Phase 2 protocol used subcutaneous injections at weekly or biweekly intervals. Exact dosing protocols remain unpublished.

Lyophilised: refrigerate 2–8 °C, protect from light. Reconstituted: use immediately or refrigerate, discard after 7–14 days per labeling.

5. Needle

—

27–30G insulin syringe, 45° angle for subcutaneous administration.

06Stack Synergy

ACE-031

— no documented stacks

Cardiogen

+ Thymalin

Moderate

View Thymalin →

Khavinson-school multi-organ bioregulator approach: thymalin (thymic peptide) addresses immune senescence while cardiogen targets cardiac tissue. Combined use in geriatric populations demonstrated normalisation of cardiovascular, endocrine, and immune parameters with reduced mortality over 6–8 years of observation.

Cardiogen: 10–20 mg SQ · 10–20 day course
Thymalin: 10–30 mg IM · concurrent or sequential courses
Frequency: 2–4 courses per year
Primary benefit: Multi-system aging mitigation, cardiovascular and immune homeostasis