ACE-031 for Muscle Growth - Quick Reference Sheet

ACE-031 for Muscle Growth

Created on 09/13/2026 – Quick Reference based on Evidence Review created using AI4L / Opus 5 Audit

An injected decoy protein that soaks up the body's own brakes on muscle growth. It enlarged muscle in both human trials, and also raised bone density and reduced body fat, without any matching gain in strength or walking ability. Development stopped over clusters of widened small blood vessels and nosebleeds. Nearly every vial tested contained a different protein entirely. (Full Review)

Protocol

Repeat-dose regimens studied
0.5 mg/kg every 4 weeks or 1.0 mg/kg every 2 weeks
Subcutaneously for 12 weeks. A planned 2.5 mg/kg arm was never dosed.
Single-dose range studied
0.02 to 3 mg/kg by subcutaneous injection
Dose-proportional exposure. Muscle enlargement significant only at 3 mg/kg.
No approved or practitioner-established protocol exists
Discontinued trial protocols only
Never approved anywhere. Every regimen above was designed by Acceleron Pharma, not a standard of care.
Time to effect
Skeletal muscle mass
29 days
Lean-mass and muscle-volume change within 29 days of a single dose; established by 12 weeks of repeat dosing.
Bone mineral density
24 weeks
Lumbar spine density rose over 24 weeks of repeat dosing in the Duchenne trial.
Fat mass
24 weeks
Fat mass fell in both drug arms while rising on placebo, reported only as a directional trend.

Benefits

Contraindications
  • Hereditary hemorrhagic telangiectasia, or a first-degree relative with it
  • Known pulmonary, hepatic or cerebral arteriovenous malformation
  • Therapeutic anticoagulation, or an inherited bleeding disorder (von Willebrand disease, hemophilia)
  • Gastrointestinal bleed or peptic ulcer within 6 months
  • Platelet count below 100 × 10⁹/L
  • Polycythemia (hematocrit above 52% men, 48% women)
  • Uncontrolled hypertension (above 160/100 mmHg)
  • Children and adolescents under 18 years
  • Pregnancy, attempting conception or breastfeeding
  • Subject to anti-doping testing
  • Other activin-pathway agents (bimagrumab, apitegromab, luspatercept, sotatercept)
Key Interactions
  • Antiplatelet drugs (aspirin, clopidogrel, ticagrelor, prasugrel)
  • Over-the-counter analgesics (aspirin, ibuprofen, naproxen, diclofenac gel)
  • Erythropoiesis-stimulating agents (epoetin alfa, darbepoetin alfa)
  • Supplements with additive bleeding effects (fish oil, vitamin E above 400 IU, Ginkgo biloba, garlic extract, nattokinase, curcumin)
  • Supplements with additive effects on muscle mass (creatine, HMB, epicatechin extracts)
  • GLP-1 receptor agonists (semaglutide, tirzepatide, liraglutide)
  • Anabolic androgenic steroids and selective androgen receptor modulators

Risk & Side Effects

  • High: Injection-site reactions
  • Medium: Telangiectasias and nosebleeds; headache
  • Low: Adulterated and misidentified grey-market product
  • Speculative: Increase in red cell mass; testicular changes and impaired fertility; vascular malformations beyond skin and mucosa

Monitoring

Marker Target Why
Hematocrit 40–48% (men), 36–44% (women) Detects the red-cell rise seen with this class
Hemoglobin 13.5–16.0 g/dL (men), 12.0–14.5 g/dL (women) Confirms a hematocrit shift is real erythropoiesis
Platelet count 200–350 × 10⁹/L Shows whether vessel fragility becomes bleeding
Ferritin 50–150 ng/mL Tracks iron drawn down by red-cell production
Blood pressure Below 120/80 mmHg Higher pressure amplifies small-vessel bleeding
Lean body mass (DXA) No established target; % change from own baseline (trial gains 3–5%) The only outcome shown to move in humans
Lumbar spine bone mineral density (DXA) T-score above -1.0 Captures the bone effect alongside muscle gain
ALT 10–26 U/L (men), 7–22 U/L (women) Baseline organ safety and concurrent substances
eGFR Above 90 mL/min/1.73 m² Baseline organ safety before an unlicensed drug

Cadence: Blood work and blood pressure at 4 weeks, then every 8–12 weeks; skin and mucosal inspection weekly; DXA at 12 and 24 weeks.

Qualitative Assessment

  • New or spreading small red vascular marks on lips, fingers, nail beds or inside the nose
  • Nosebleed frequency and duration, and any gum bleeding when brushing
  • Headache frequency and character compared with the pre-exposure baseline
  • Girth measurements and progressive-overload logs, as a cross-check on whether added size is doing work
  • Energy, training recovery and sleep quality, which drift first when red cell mass or iron status changes