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Psychostimulant
Psychostimulant is a Small molecule drug developed by Hospital de Clinicas de Porto Alegre. It is currently in Phase 1 development. Also known as: Methilphenidate, Lisdexamfetamine.
Psychostimulants are a class of small molecule drugs that increase alertness and are used for various purposes, such as enhancing attention, motivation, cognition, mood, and physical performance. They have been studied in clinical trials for conditions including cognitive impairment, ADHD, fatigue, and prostate cancer, with interventions such as Lisdexamfetamine and Placebo oral capsule.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Psychostimulant |
|---|---|
| Also known as | Methilphenidate, Lisdexamfetamine |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- LRFN5 and OLFM4 in Methamphetamine-Induced Psychosis
- α-N-acetylgalactosaminidase in Methamphetamine Psychosis
- Study of the Nutritional, Inflammatory, and Metabolic Endophenotypes of Attention-Deficit/Hyperactivity Disorder (ADHD) (NA)
- Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder (EARLY_PHASE1)
- Modafinil and Cognitive Function in POTS (EARLY_PHASE1)
- Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men
- Pharmacogenomics of Stimulant Treatment Response
- A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD) (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:
- Psychostimulant CI brief — competitive landscape report
- Psychostimulant updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI
Frequently asked questions about Psychostimulant
What is Psychostimulant?
Who makes Psychostimulant?
Is Psychostimulant also known as anything else?
What development phase is Psychostimulant in?
Related
- Manufacturer: Hospital de Clinicas de Porto Alegre — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Methilphenidate, Lisdexamfetamine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing