TRIAL RESULTS · SIDE EFFECTS
SS-31 (elamipretide) side effects
ANSWER
In 5 placebo-controlled trials with posted results, the most common side effects of SS-31 (elamipretide) were injection site erythema 63.8% (placebo 44.7%), injection site pain 29.4% (placebo 21.8%), nasopharyngitis 5.5% (placebo 2.4%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
6
with an arm on SS-31 (elamipretide), of 30 registered
Against placebo
5
placebo-controlled trials
People in those trials
546
on SS-31 (elamipretide) · 472 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, SS-31 (elamipretide) beside placebo
Share of people with each side effect in 5 placebo-controlled trials with posted results: 546 people on SS-31 (elamipretide) (all doses), 472 on placebo, same trials. Listed only when reported for at least half of the people on SS-31 (elamipretide). Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 249 side effects reported
Every trial with posted results and an arm on SS-31 (elamipretide) (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | SS-31 (elamipretide) | Placebo | Trials |
|---|---|---|---|---|
| Injection site erythema | General disorders | 63.8% (178 of 279) | 44.7% | 3 |
| Injection site pruritus | General disorders | 66.9% (174 of 260) | 37.6% | 3 |
| Injection site pain | General disorders | 30.0% (92 of 307) | 21.8% | 4 |
| Injection site swelling | General disorders | 33.9% (78 of 230) | 12.7% | 2 |
| Injection site induration | General disorders | 21.3% (59 of 277) | 19.9% | 3 |
| Injection Site Pruritus | General disorders | 39.3% (46 of 117) | 0.0% | 1 |
| Injection Site Pain | General disorders | 28.2% (33 of 117) | 10.2% | 1 |
| Headache | Nervous system disorders | 5.4% (31 of 574) | 3.4% | 6 |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 20.0% (30 of 150) | 12.9% | 1 |
| Hypokalaemia | Metabolism and nutrition disorders | 16.3% (29 of 178) | 18.4% | 2 |
| Nasopharyngitis | Infections and infestations | 7.1% (28 of 394) | 2.4% | 4 |
| Cardiac Failure | Cardiac disorders | 18.7% (28 of 150) | 19.7% | 1 |
| injection site urticaria | General disorders | 12.9% (26 of 202) | 3.8% | 1 |
| Fall | Injury, poisoning and procedural complications | 6.6% (25 of 377) | 4.7% | 4 |
| Injection Site Erythema | General disorders | 18.8% (22 of 117) | 0.0% | 1 |
| Nausea | Gastrointestinal disorders | 4.9% (21 of 427) | 4.7% | 4 |
| Dizziness | Nervous system disorders | 3.5% (20 of 574) | 2.5% | 6 |
| Hypertension | Vascular disorders | 3.7% (19 of 516) | 2.7% | 4 |
| Injection site urticaria | General disorders | 32.8% (19 of 58) | 0.0% | 2 |
| injection site nodule | General disorders | 9.4% (19 of 202) | 4.7% | 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3.4% (17 of 497) | 2.2% | 4 |
| Fatigue | General disorders | 6.1% (17 of 277) | 3.8% | 3 |
| Eosinophil count increased | Investigations | 7.4% (17 of 230) | 3.3% | 2 |
| Injection Site Haemorrhage | General disorders | 14.5% (17 of 117) | 6.8% | 1 |
| Injection Site Induration | General disorders | 13.7% (16 of 117) | 5.1% | 1 |
| Diarrhoea | Gastrointestinal disorders | 3.3% (15 of 457) | 6.1% | 5 |
| Injection Site Bruising | General disorders | 12.8% (15 of 117) | 18.6% | 1 |
| Injection site mass | General disorders | 18.7% (14 of 75) | 0.0% | 2 |
| injection site bruising | General disorders | 6.9% (14 of 202) | 15.6% | 1 |
| Upper respiratory tract Infection | Infections and infestations | 6.9% (14 of 202) | 6.6% | 1 |
| Vomiting | Gastrointestinal disorders | 7.3% (13 of 178) | 4.8% | 2 |
| Diabetes mellitus | Metabolism and nutrition disorders | 6.6% (13 of 197) | 4.1% | 2 |
| injection site mass | General disorders | 6.4% (13 of 202) | 2.8% | 1 |
| Injection Site Mass | General disorders | 11.1% (13 of 117) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 2.4% (12 of 497) | 1.7% | 4 |
| Anxiety | Psychiatric disorders | 5.3% (12 of 225) | 8.8% | 3 |
| Pyrexia | General disorders | 2.6% (11 of 427) | 3.1% | 4 |
| Angina Pectoris | Cardiac disorders | 7.3% (11 of 150) | 4.1% | 1 |
| Injection Site Swelling | General disorders | 9.4% (11 of 117) | 0.0% | 1 |
| Urinary Tract Infection | Infections and infestations | 2.9% (10 of 349) | 2.3% | 3 |
| Injection Site Hypertrophy | General disorders | 8.5% (10 of 117) | 6.8% | 1 |
| Constipation | Gastrointestinal disorders | 1.7% (9 of 544) | 1.8% | 5 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.3% (9 of 394) | 1.7% | 4 |
| Non-cardiac chest pain | General disorders | 6.0% (9 of 150) | 3.4% | 1 |
| Intracardiac Thrombus | Cardiac disorders | 6.0% (9 of 150) | 6.8% | 1 |
| injection site haemorrhage | General disorders | 4.5% (9 of 202) | 8.5% | 1 |
| Back pain | Musculoskeletal and connective tissue disorders | 3.8% (8 of 208) | 5.1% | 3 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2.9% (8 of 277) | 4.2% | 3 |
| Sinusitis | Infections and infestations | 3.5% (8 of 230) | 3.3% | 2 |
| Neovascular Age-related Macular Degeneration | Eye disorders | 6.8% (8 of 117) | 8.5% | 1 |
| Gastroenteritis viral | Infections and infestations | 9.3% (7 of 75) | 0.0% | 2 |
| Chest pain | General disorders | 3.0% (7 of 230) | 0.0% | 2 |
| Insomnia | Psychiatric disorders | 4.7% (7 of 150) | 0.7% | 1 |
| Eosinophil Count Increased | Investigations | 6.0% (7 of 117) | 0.0% | 1 |
| Urinary tract infection | Infections and infestations | 3.4% (6 of 178) | 2.0% | 2 |
| Injection site bruising | General disorders | 10.3% (6 of 58) | 6.7% | 2 |
| Blood lactic acid increased | Investigations | 2.6% (6 of 230) | 0.9% | 2 |
| Anaemia | Blood and lymphatic system disorders | 4.0% (6 of 150) | 4.1% | 1 |
| Atrial Fibrillation | Cardiac disorders | 4.0% (6 of 150) | 5.4% | 1 |
| Hyperlipidaemia | Metabolism and nutrition disorders | 4.0% (6 of 150) | 6.1% | 1 |
| Upper respiratory tract infection | Infections and infestations | 2.6% (5 of 192) | 1.2% | 3 |
| Syncope | Nervous system disorders | 2.8% (5 of 178) | 0.0% | 2 |
| Hypotension | Vascular disorders | 2.5% (5 of 197) | 3.5% | 2 |
| Abdominal Pain | Gastrointestinal disorders | 2.2% (5 of 232) | 0.8% | 2 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | 2.2% (5 of 232) | 0.8% | 2 |
| Influenza | Infections and infestations | 2.2% (5 of 230) | 0.9% | 2 |
| Migraine | Nervous system disorders | 2.2% (5 of 230) | 0.9% | 2 |
| Rash | Skin and subcutaneous tissue disorders | 2.2% (5 of 230) | 0.9% | 2 |
| Cardiac Failure Congestive | Cardiac disorders | 3.3% (5 of 150) | 3.4% | 1 |
| Coronary Artery Disease | Cardiac disorders | 3.3% (5 of 150) | 3.4% | 1 |
| Glucose Tolerance Impairment | Metabolism and nutrition disorders | 3.3% (5 of 150) | 4.1% | 1 |
| Injection Site Irritation | General disorders | 4.3% (5 of 117) | 0.0% | 1 |
| Injection Site Urticaria | General disorders | 4.3% (5 of 117) | 0.0% | 1 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1.5% (4 of 267) | 0.0% | 2 |
| Back Pain | Musculoskeletal and connective tissue disorders | 1.1% (4 of 352) | 0.8% | 2 |
| Hypoaesthesia | Nervous system disorders | 1.7% (4 of 230) | 1.9% | 2 |
| Ejection fraction decreased | Investigations | 2.7% (4 of 150) | 0.7% | 1 |
| Ventricular extrasystoles | Cardiac disorders | 2.7% (4 of 150) | 0.7% | 1 |
| Ventricular Tachycardia | Cardiac disorders | 2.7% (4 of 150) | 2.7% | 1 |
| Haematoma | Vascular disorders | 2.7% (4 of 150) | 2.7% | 1 |
| Cardiogenic Shock | Cardiac disorders | 2.7% (4 of 150) | 0.0% | 1 |
| Injection site rash | General disorders | 14.3% (4 of 28) | - | 1 |
| Concussion | Injury, poisoning and procedural complications | 14.3% (4 of 28) | - | 1 |
| Contusion | Injury, poisoning and procedural complications | 14.3% (4 of 28) | - | 1 |
| Blood creatine phosphokinase increased | Investigations | 2.0% (4 of 202) | 0.5% | 1 |
| Cholelithiasis | Hepatobiliary disorders | 0.9% (3 of 347) | 0.4% | 3 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 4.0% (3 of 75) | 0.0% | 2 |
| Injection site haemorrhage | General disorders | 4.0% (3 of 75) | 0.0% | 2 |
| Urticaria | Skin and subcutaneous tissue disorders | 1.3% (3 of 230) | 0.5% | 2 |
| Hypotonia | Nervous system disorders | 2.0% (3 of 150) | 2.0% | 1 |
| Catheter site pain | General disorders | 2.0% (3 of 150) | 0.7% | 1 |
| Coronary Artery Stenosis | Cardiac disorders | 2.0% (3 of 150) | 2.7% | 1 |
| Mitral Valve Incompetence | Cardiac disorders | 2.0% (3 of 150) | 0.7% | 1 |
| Hyponatraemia | Metabolism and nutrition disorders | 2.0% (3 of 150) | 1.4% | 1 |
| Type 2 Diabetes mellitus | Metabolism and nutrition disorders | 2.0% (3 of 150) | 0.7% | 1 |
| Injection site irritation | General disorders | 10.0% (3 of 30) | 3.3% | 1 |
| Tachycardia | Cardiac disorders | 10.7% (3 of 28) | - | 1 |
| Abdominal distension | Gastrointestinal disorders | 10.7% (3 of 28) | - | 1 |
| Abdominal pain | Gastrointestinal disorders | 10.7% (3 of 28) | - | 1 |
| Abdominal pain upper | Gastrointestinal disorders | 10.7% (3 of 28) | - | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
QUESTIONS
Does ss-31 (elamipretide) cause injection site erythema?
In 5 placebo-controlled trials with posted results, 63.8% of people on ss-31 (elamipretide) reported injection site erythema, against 44.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does ss-31 (elamipretide) cause injection site pain?
In 5 placebo-controlled trials with posted results, 29.4% of people on ss-31 (elamipretide) reported injection site pain, against 21.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does ss-31 (elamipretide) cause nasopharyngitis?
In 5 placebo-controlled trials with posted results, 5.5% of people on ss-31 (elamipretide) reported nasopharyngitis, against 2.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does ss-31 (elamipretide) cause nausea?
In 5 placebo-controlled trials with posted results, 4.8% of people on ss-31 (elamipretide) reported nausea, against 4.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does ss-31 (elamipretide) cause headache?
In 5 placebo-controlled trials with posted results, 4.4% of people on ss-31 (elamipretide) reported headache, against 3.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
30 registered clinical trials of SS-31 (elamipretide)
The 10 most recently updated are listed.
| NCT07531251 | Clinical Trial in Patients With Barth Syndrome- 4TAZPower Status: RECRUITING · Updated 2026-07-13 |
|---|---|
| NCT06373731 | ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) Status: ACTIVE_NOT_RECRUITING · Updated 2026-05-20 |
| NCT05168774 | FRDA Investigator Initiated Study (IIS) With Elamipretide Status: COMPLETED · Updated 2025-12-12 |
| NCT07275424 | Study of Healthy Aging and Physical Function With Elamipretide Status: RECRUITING · Updated 2025-12-10 |
| NCT05162768 | Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD) Status: COMPLETED · Updated 2025-10-24 |
| NCT04689360 | An Intermediate Size Expanded Access Protocol of Elamipretide Status: AVAILABLE · Updated 2025-02-14 |
| NCT03891875 | ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA Status: COMPLETED · Updated 2024-07-12 |
| NCT03098797 | A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome Status: COMPLETED · Updated 2024-04-16 |
| NCT03323749 | A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension Status: TERMINATED · Updated 2022-01-24 |
| NCT02976038 | Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM) Status: TERMINATED · Updated 2021-12-17 |
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