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Meilax (ETHYL LOFLAZEPATE)

Phase 2 active Small molecule

Meilax (generic name: ETHYL LOFLAZEPATE) is a ethyl loflazepate drug. It is currently in Phase 2 development for Anxiety, Depressive disorder.

Meilax works by enhancing the activity of a neurotransmitter called gamma-aminobutyric acid (GABA), which helps to calm the brain and reduce anxiety.

Meilax, also known as ethyl loflazepate, is a small molecule drug in the benzodiazepine class. It is used to treat anxiety and depressive disorders. The commercial status of Meilax is currently unknown, and it is not clear if it is patented or available as a generic medication. Further research is needed to determine its key safety considerations and pharmacokinetic properties.

Likelihood of approval
12.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameETHYL LOFLAZEPATE
Drug classethyl loflazepate
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain is like a busy city with lots of people talking and moving around. GABA is like a traffic cop that helps to slow down the traffic and keep everything calm. Meilax helps the traffic cop to do its job more effectively, which can help to reduce feelings of anxiety and stress.

Approved indications

Common side effects

Competitive intelligence

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

Frequently asked questions about Meilax

What is Meilax?

Meilax (ETHYL LOFLAZEPATE) is a ethyl loflazepate drug, indicated for Anxiety, Depressive disorder.

How does Meilax work?

Meilax works by enhancing the activity of a neurotransmitter called gamma-aminobutyric acid (GABA), which helps to calm the brain and reduce anxiety.

What is Meilax used for?

Meilax is indicated for Anxiety, Depressive disorder.

What is the generic name of Meilax?

ETHYL LOFLAZEPATE is the generic (nonproprietary) name of Meilax.

What drug class is Meilax in?

Meilax belongs to the ethyl loflazepate class. See all ethyl loflazepate drugs at /class/ethyl-loflazepate.

What development phase is Meilax in?

Meilax is in Phase 2.

What are the side effects of Meilax?

Common side effects of Meilax include Altered state of consciousness, Parkinsonism, Tongue oedema, Suicide attempt, Neuroleptic malignant syndrome, Irritability.

Related

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