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Methyl Cysteine (MECYSTEINE)
Methyl Cysteine (generic name: MECYSTEINE) is a mecysteine drug. It is currently in Phase 2 development.
Methyl cysteine works by binding to cystine and preventing its crystallization.
Methyl cysteine is a small molecule. It has been studied in clinical trials for various conditions, including acute upper respiratory tract infection, female infertility, and unexplained infertility.
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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 | MECYSTEINE |
|---|---|
| Drug class | mecysteine |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 2 |
Mechanism of action
Imagine cystine as a puzzle piece that can fit together to form a stone. Methyl cysteine acts like a puzzle piece that fits into the same spot, but it's slightly different, so the cystine pieces can't fit together to form a stone. This helps prevent the formation of cystine stones in the kidneys and urinary tract.
Approved indications
Common side effects
Key clinical trials
- A Phase I, Open-label, Single-dose, Randomized, 2-way Cross-over Study Designed to Examine the Relative Bioavailability of Guaifenesin When a Mucinex Extended Release 600 mg Bi-layer Tablet is Taken U (Phase 1)
- A Phase I/II Study of Methylselenocysteine (MSC) in Combination With Immunochemotherapy (R-ICE) in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) (Phase 1)
- Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study) (Phase 4)
- Study of the Effect of 12-week Dietary Supplementation With a Multicomponent Nutritional Supplement on Nails and Skin: a Randomized, Double-blind Placebo-controlled Study (NA)
- Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days (Phase 2)
- Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males (Phase 1)
- Comparison of Vaginal Estradiol and Oral Guaifenesin Interventions in Patients Undergoing Ovulation Induction With Clomiphene Citrate (NA)
- Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper (Phase 2)
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:
- Methyl Cysteine CI brief — competitive landscape report
- Methyl Cysteine updates RSS · CI watch RSS
Frequently asked questions about Methyl Cysteine
What is Methyl Cysteine?
How does Methyl Cysteine work?
What is the generic name of Methyl Cysteine?
What drug class is Methyl Cysteine in?
What development phase is Methyl Cysteine in?
Related
- Drug class: All mecysteine drugs
- Therapeutic area: All drugs in Nephrology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing