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SPN-810 (36 mg)
SPN-810 (36 mg) is a mood stabilizer Small molecule drug developed by Supernus Pharmaceuticals, Inc.. It is currently in Phase 3 development for Disruptive mood dysregulation disorder (DMDD).
SPN-810 is a proprietary formulation of a divalproex sodium extended-release product designed to treat disruptive mood dysregulation disorder (DMDD).
SPN-810 is an experimental medication being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Impulsive Aggression. It is administered in doses of 18 mg and 36 mg, in addition to a placebo, as part of clinical trials to assess its efficacy and safety.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | SPN-810 (36 mg) |
|---|---|
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Drug class | mood stabilizer |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
The exact mechanism of action of SPN-810 is not fully understood, but it is believed to work by stabilizing mood and reducing the risk of suicidal behavior. SPN-810 is a formulation of divalproex sodium, which is a mood stabilizer that has been used to treat various conditions, including bipolar disorder and epilepsy.
Approved indications
- Disruptive mood dysregulation disorder (DMDD)
Common side effects
- Nausea
- Dizziness
- Headache
- Somnolence
- Fatigue
- Weight gain
- Increased appetite
- Rash
- Diarrhea
- Vomiting
Key clinical trials
- Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD (PHASE2)
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (PHASE3)
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (PHASE3)
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (PHASE3)
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:
- SPN-810 (36 mg) CI brief — competitive landscape report
- SPN-810 (36 mg) updates RSS · CI watch RSS
- Supernus Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about SPN-810 (36 mg)
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Related
- Drug class: All mood stabilizer drugs
- Manufacturer: Supernus Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Disruptive mood dysregulation disorder (DMDD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing