Last reviewed 2026-04-22 · How we verify

Acetyllevocarnitine Hydrochloride Tablets

Haisco Pharmaceutical Group Co., Ltd. · Phase 3 active Small molecule

Acetyllevocarnitine Hydrochloride Tablets is a Metabolic agent / Mitochondrial function enhancer Small molecule drug developed by Haisco Pharmaceutical Group Co., Ltd.. It is currently in Phase 3 development for Age-related cognitive decline, Peripheral neuropathy, Myasthenia gravis.

Acetyl-L-carnitine enhances cellular energy production by facilitating the transport of long-chain fatty acids into mitochondria for beta-oxidation.

Acetyl-L-carnitine enhances cellular energy production by facilitating the transport of long-chain fatty acids into mitochondria for beta-oxidation. Used for Age-related cognitive decline, Peripheral neuropathy, Myasthenia gravis.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Acetyllevocarnitine Hydrochloride Tablets
Sponsor	Haisco Pharmaceutical Group Co., Ltd.
Drug class	Metabolic agent / Mitochondrial function enhancer
Target	Carnitine palmitoyltransferase (CPT) system
Modality	Small molecule
Therapeutic area	Neurology / Metabolic disorders
Phase	Phase 3

Mechanism of action

Acetyl-L-carnitine is an acetylated form of L-carnitine that plays a critical role in mitochondrial fatty acid metabolism. It acts as a carrier molecule that transports activated long-chain fatty acids across the inner mitochondrial membrane, enabling their oxidation to generate ATP. Additionally, acetyl-L-carnitine serves as an acetyl donor and may have neuroprotective and antioxidant properties.

Approved indications

Age-related cognitive decline
Peripheral neuropathy
Myasthenia gravis
Metabolic disorders associated with carnitine deficiency

Common side effects

Nausea
Gastrointestinal discomfort
Headache
Dizziness

Key clinical trials

Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Acetyllevocarnitine Hydrochloride Tablets CI brief — competitive landscape report
Acetyllevocarnitine Hydrochloride Tablets updates RSS · CI watch RSS
Haisco Pharmaceutical Group Co., Ltd. portfolio CI

Frequently asked questions about Acetyllevocarnitine Hydrochloride Tablets

What is Acetyllevocarnitine Hydrochloride Tablets?

Acetyllevocarnitine Hydrochloride Tablets is a Metabolic agent / Mitochondrial function enhancer drug developed by Haisco Pharmaceutical Group Co., Ltd., indicated for Age-related cognitive decline, Peripheral neuropathy, Myasthenia gravis.

How does Acetyllevocarnitine Hydrochloride Tablets work?

Acetyl-L-carnitine enhances cellular energy production by facilitating the transport of long-chain fatty acids into mitochondria for beta-oxidation.

What is Acetyllevocarnitine Hydrochloride Tablets used for?

Acetyllevocarnitine Hydrochloride Tablets is indicated for Age-related cognitive decline, Peripheral neuropathy, Myasthenia gravis, Metabolic disorders associated with carnitine deficiency.

Who makes Acetyllevocarnitine Hydrochloride Tablets?

Acetyllevocarnitine Hydrochloride Tablets is developed by Haisco Pharmaceutical Group Co., Ltd. (see full Haisco Pharmaceutical Group Co., Ltd. pipeline at /company/haisco-pharmaceutical-group-co-ltd).

What drug class is Acetyllevocarnitine Hydrochloride Tablets in?

Acetyllevocarnitine Hydrochloride Tablets belongs to the Metabolic agent / Mitochondrial function enhancer class. See all Metabolic agent / Mitochondrial function enhancer drugs at /class/metabolic-agent-mitochondrial-function-enhancer.

What development phase is Acetyllevocarnitine Hydrochloride Tablets in?

Acetyllevocarnitine Hydrochloride Tablets is in Phase 3.

What are the side effects of Acetyllevocarnitine Hydrochloride Tablets?

Common side effects of Acetyllevocarnitine Hydrochloride Tablets include Nausea, Gastrointestinal discomfort, Headache, Dizziness.

What does Acetyllevocarnitine Hydrochloride Tablets target?

Acetyllevocarnitine Hydrochloride Tablets targets Carnitine palmitoyltransferase (CPT) system and is a Metabolic agent / Mitochondrial function enhancer.

Drug class: All Metabolic agent / Mitochondrial function enhancer drugs
Target: All drugs targeting Carnitine palmitoyltransferase (CPT) system
Manufacturer: Haisco Pharmaceutical Group Co., Ltd. — full pipeline
Therapeutic area: All drugs in Neurology / Metabolic disorders
Indication: Drugs for Age-related cognitive decline
Indication: Drugs for Peripheral neuropathy
Indication: Drugs for Myasthenia gravis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing