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Metanopirone Citrate (TANDOSPIRONE)
Metanopirone Citrate (generic name: TANDOSPIRONE) is a tandospirone drug. It is currently in Phase 2 development for Bruxism (teeth grinding).
Tandospirone works by binding to and modulating the activity of dopamine D(4) receptors in the brain.
Metanopirone Citrate is a small molecule with synonyms including SEDIEL, SM-3997, and Tandospirone Citrate.
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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 | TANDOSPIRONE |
|---|---|
| Drug class | tandospirone |
| Target | D(4) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain is like a city with many different streets and intersections. Dopamine is like a traffic signal that helps control the flow of messages between different parts of the city. Tandospirone helps to adjust the traffic signal, reducing the messages that can lead to teeth grinding and other symptoms of Bruxism.
Approved indications
- Bruxism (teeth grinding)
Common side effects
Key clinical trials
- Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder (PHASE4)
- Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety (PHASE4)
- A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease (PHASE4)
- Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia (PHASE4)
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:
- Metanopirone Citrate CI brief — competitive landscape report
- Metanopirone Citrate updates RSS · CI watch RSS
Frequently asked questions about Metanopirone Citrate
What is Metanopirone Citrate?
How does Metanopirone Citrate work?
What is Metanopirone Citrate used for?
What is the generic name of Metanopirone Citrate?
What drug class is Metanopirone Citrate in?
What development phase is Metanopirone Citrate in?
What does Metanopirone Citrate target?
Related
- Drug class: All tandospirone drugs
- Target: All drugs targeting D(4) dopamine receptor
- Therapeutic area: All drugs in Other
- Indication: Drugs for Bruxism (teeth grinding)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing