Evigrade

Alpha-lipoic acid (thioctic acid, ALA)

Antioxidant; cofactor of pyruvate and α-ketoglutarate dehydrogenase

ATC code: A16AX01(Thioctic acid)

Brand names: Alpha-lipoic acid (various), Thioctacid HR

Updated · Methodology

Indications

B

Diabetic polyneuropathy

Adjunct

Adjunct therapy for painful diabetic polyneuropathy. AEMPS approves Thiogamma 600 (oral, nregistro 88703; infusion, 90841) in confirmed disease: IV 600 mg/day for 2–3 weeks, then oral maintenance 300–600 mg/day with periodic review. The symptomatic effect is more convincing for a short IV course: the ALADIN and SYDNEY trials and the Mijnhout 2012 meta-analysis showed moderate reduction of pain and paraesthesia. Evidence for long-term oral use is weaker: the 4-year NATHAN 1 trial missed its primary endpoint. EFNS positions the drug as adjunctive, not first-line: first-line options are gabapentin/pregabalin or duloxetine. If pain is severe or ALA does not work after 4–6 weeks, switching therapy with an endocrinologist or neurologist is appropriate.

ICD-10: G63.2 · ICD-11: 8C03.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Liver support and “hepatoprotection”

Not recommended

Alpha-lipoic acid (thioctic acid, ALA) is an antioxidant that supplements and ads promote as a "liver support" or hepatoprotective agent. Studies have not shown convincing benefit for this use, and there is no good evidence base for protecting liver cells or supporting liver function. What actually helps depends on the cause of liver disease, such as stopping alcohol, losing weight in fatty liver disease, or treating viral hepatitis, so discuss the approach with your doctor. The substance is harmless in this role

D

Type 2 diabetes mellitus

Not recommended

ALA is marketed as a glucose-lowering drug that can replace metformin. Standards of Care 2024 do not recommend it for glycaemic control: a meta-analysis of RCTs (Akbari 2018) shows a statistically significant but clinically small reduction in , insufficient to replace glucose-lowering therapy. AEMPS registered the drug only for polyneuropathy, not for diabetes itself. Replacing metformin or insulin with ALA leads to decompensation and ketoacidosis risk. Concerns about glycaemic control require regimen review with an endocrinologist, not supplement self-prescription.

ICD-10: E11 · ICD-11: 5A11

F

Anti-aging and longevity

Not recommended

Biohacker blogs place ALA alongside metformin and NMN in the «longevity stack». No trials in healthy adults with mortality or age-related disease endpoints exist. AEMPS and have not registered the drug as a geroprotector. Harm is documented: ALA has been linked to insulin autoimmune syndrome (Hirata disease) with severe spontaneous hypoglycaemia, notably in carriers of HLA-DRB1*04:06 – with no longevity benefit this is a net negative. Taking ALA «for ageing» sells hope, not treatment. Evidence-based ageing-slowing factors are physical activity, blood-pressure control, smoking cessation and adequate sleep.

F

Weight loss

Not recommended

On iHerb and Instagram ALA is sold as a «fat burner» and «weight-loss drug». Meta-analyses of RCTs (Kucukgoncu 2017; Vajdi 2020) show that ALA produces roughly 1.3–2.3 kg more weight loss than placebo – a statistically significant but clinically small effect. AEMPS has not approved ALA for weight reduction. There is also documented harm: ALA has been linked to insulin autoimmune syndrome (Hirata disease) with severe spontaneous hypoglycaemia, a risk that compounds in people on glucose-lowering drugs. Evidence-based options are caloric deficit, physical activity and, where indicated, GLP-1 agonists (semaglutide, liraglutide) under medical supervision. Medical help for obesity should be discussed with an endocrinologist, not a supplement seller.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A disulphide carrying two SH groups in its reduced form (dihydrolipoic acid). Cofactor of pyruvate and α-ketoglutarate dehydrogenase in mitochondrial oxidative decarboxylation. Scavenges free radicals, regenerates vitamins C and E and chelates transition metals. Oral bioavailability is 30–40%; the R-enantiomer is more active than the racemate. In Germany and Spain Thioctacid 600 is registered as a drug for diabetic polyneuropathy; in most other countries it is sold as a supplement.

Safety

Contraindications

  • Hypersensitivity to alpha-lipoic acid
  • Age under 18 years
  • Thiamine deficiency (without prior vitamin B1 correction)

Serious adverse effects

  • Anaphylactic reactions with IV administration
  • Insulin autoimmune syndrome (Hirata syndrome) with severe hypoglycaemia – rare, described in HLA-DR4 carriers
  • Thrombocytopenia
  • Seizures with rapid IV infusion

Common adverse effects

  • Nausea, vomiting
  • Epigastric pain
  • Skin rash
  • Altered urine odour
  • Hypoglycaemia in patients with diabetes

Pregnancy: can you take Alpha-lipoic acid (thioctic acid, ALA)?

Pregnancy data are limited. AEMPS does not recommend Thioctacid 600 in gestation because of inadequate studies. ALA supplements are avoided in pregnancy.

Breastfeeding: can you take Alpha-lipoic acid (thioctic acid, ALA)?

Not preferred. Hale L4. No milk transfer data available. AEMPS does not recommend Thioctacid 600 during lactation.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Alpha-lipoic acid (thioctic acid, ALA) used for?

Alpha-lipoic acid (thioctic acid, ALA) is evaluated for the following indications with varying evidence strength: Diabetic polyneuropathy (evidence tier B), Type 2 diabetes mellitus (evidence tier D), Liver support and “hepatoprotection” (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Alpha-lipoic acid (thioctic acid, ALA)?

Common side effects of Alpha-lipoic acid (thioctic acid, ALA) (≥ 1 in 100): Nausea, vomiting, Epigastric pain, Skin rash, Altered urine odour, Hypoglycaemia in patients with diabetes. See the Safety section for uncommon and serious reactions.

Is Alpha-lipoic acid (thioctic acid, ALA) safe during pregnancy?

Pregnancy data are limited. AEMPS does not recommend Thioctacid 600 in gestation because of inadequate studies. ALA supplements are avoided in pregnancy.

Is Alpha-lipoic acid (thioctic acid, ALA) compatible with breastfeeding?

Not preferred. Hale L4. No milk transfer data available. AEMPS does not recommend Thioctacid 600 during lactation.

Who should not take Alpha-lipoic acid (thioctic acid, ALA)?

Alpha-lipoic acid (thioctic acid, ALA) is contraindicated in: Hypersensitivity to alpha-lipoic acid; Age under 18 years; Thiamine deficiency (without prior vitamin B1 correction). Full list in the Safety section.

Other drugs in this group

Astragalus root (Astragalus membranaceus; Huang Qi in traditional Chinese medicine), Beta-alanine, Betaine (trimethylglycine, TMG), Chlorophyll (chlorophyllin copper-sodium complex), Cytoflavin (succinic acid, nicotinamide, riboflavin, inosine complex), L-arginine, L-ornithine, Medium-chain triglycerides (MCT, coconut oil C8–C10)