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Minocyline
Minocyline is a Small molecule drug developed by German Parkinson Study Group (GPS). It is currently in Phase 3 development.
Minocycline is a medication that has been studied in clinical trials for various conditions, including Fragile X Syndrome, Major Depressive Disorder, Multi-System-Atrophy, and At Risk Mental State (ARMS). It has been used as an intervention in these trials, with one completed trial specifically examining its effectiveness as an add-on treatment for Fragile X Syndrome.
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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).
| 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 | Minocyline |
|---|---|
| Sponsor | German Parkinson Study Group (GPS) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Stony Brook Medicine Anti-Inflammatory Trial (PHASE4)
- Adjunct Minocyline in Treatment-resistant Depression (PHASE2)
- Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States (PHASE2)
- Study About Efficacy and Safety to Treat Multi-System-Atrophy (PHASE3)
- Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome (NA)
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:
- Minocyline CI brief — competitive landscape report
- Minocyline updates RSS · CI watch RSS
- German Parkinson Study Group (GPS) portfolio CI
Frequently asked questions about Minocyline
What is Minocyline?
Who makes Minocyline?
What development phase is Minocyline in?
Related
- Manufacturer: German Parkinson Study Group (GPS) — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing