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Quaterin (MELDONIUM)
Quaterin (generic name: MELDONIUM) is a meldonium drug. It is currently in Phase 2 development.
Meldonium works by inhibiting the enzyme gamma-butyrobetaine dioxygenase, which is involved in the production of carnitine.
Meldonium, also known as Quaterin, is a small molecule drug that targets gamma-butyrobetaine dioxygenase. It is classified as a meldonium drug class and its commercial status is unknown. Meldonium is used to treat various conditions, but its approved indications are not specified. The drug has a half-life of 6.2 hours, but its bioavailability and off-patent status are unknown. As a pharma professional, it is essential to consider the key safety considerations of meldonium.
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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).
| 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 name | MELDONIUM |
|---|---|
| Drug class | meldonium |
| Target | Gamma-butyrobetaine dioxygenase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 2 |
Mechanism of action
Think of carnitine like a special delivery truck that helps transport energy to our cells. Meldonium blocks the production of this truck, which can help improve heart function and reduce fatigue. This is especially helpful for people with certain heart conditions or those who are physically active.
Approved indications
Common side effects
Key clinical trials
- Novel Approach to Increase EPA and DHA Levels (PHASE1)
- Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue (PHASE1,PHASE2)
- Efficacy of the Therapy With BRAINMAX® Using fMRI for the Treatment of Patients With Asthenia After COVID-19 (PHASE4)
- Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19 (PHASE4)
- Mildronate for Acute Ischemic Stroke (PHASE2)
- Efficacy and Safety of Mildronate for Acute Ischemic Stroke (PHASE2)
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:
- Quaterin CI brief — competitive landscape report
- Quaterin updates RSS · CI watch RSS
Frequently asked questions about Quaterin
What is Quaterin?
How does Quaterin work?
What is the generic name of Quaterin?
What drug class is Quaterin in?
What development phase is Quaterin in?
What does Quaterin target?
Related
- Drug class: All meldonium drugs
- Target: All drugs targeting Gamma-butyrobetaine dioxygenase
- Therapeutic area: All drugs in Metabolic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing