Last reviewed 2026-06-02 · How we verify

double blind PR OROS methylphenidate

Janssen-Cilag International NV · Phase 3 active Small molecule Under review Quality 0/100

double blind PR OROS methylphenidate is a Central nervous system stimulant Small molecule drug developed by Janssen-Cilag International NV. It is currently in Phase 3 development for Attention deficit hyperactivity disorder (ADHD).

Methylphenidate is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain.

Double-blind studies have evaluated the effectiveness and safety of prolonged release (PR) OROS methylphenidate in adults with Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Disorder With Hyperactivity, and Attention Deficit Hyperactivity Disorder. Prolonged release (PR) OROS methylphenidate is a small molecule that acts as a dopamine transporter inhibitor, specifically targeting the sodium-dependent dopamine transporter.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Big-pharma sponsor +3.0pp
Janssen-Cilag International NV is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	double blind PR OROS methylphenidate
Sponsor	Janssen-Cilag International NV
Drug class	Central nervous system stimulant
Modality	Small molecule
Therapeutic area	Central Nervous System
Phase	Phase 3

Mechanism of action

By increasing the levels of these neurotransmitters, methylphenidate helps to improve attention and reduce impulsivity in individuals with attention deficit hyperactivity disorder (ADHD).

Approved indications

Attention deficit hyperactivity disorder (ADHD)

Common side effects

Nausea
Headache
Insomnia
Dry mouth
Anxiety

Key clinical trials

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:

double blind PR OROS methylphenidate CI brief — competitive landscape report
double blind PR OROS methylphenidate updates RSS · CI watch RSS
Janssen-Cilag International NV portfolio CI

Frequently asked questions about double blind PR OROS methylphenidate

What is double blind PR OROS methylphenidate?

double blind PR OROS methylphenidate is a Central nervous system stimulant drug developed by Janssen-Cilag International NV, indicated for Attention deficit hyperactivity disorder (ADHD).

How does double blind PR OROS methylphenidate work?

Methylphenidate is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain.

What is double blind PR OROS methylphenidate used for?

double blind PR OROS methylphenidate is indicated for Attention deficit hyperactivity disorder (ADHD).

Who makes double blind PR OROS methylphenidate?

double blind PR OROS methylphenidate is developed by Janssen-Cilag International NV (see full Janssen-Cilag International NV pipeline at /company/janssen-cilag-international-nv).

What drug class is double blind PR OROS methylphenidate in?

double blind PR OROS methylphenidate belongs to the Central nervous system stimulant class. See all Central nervous system stimulant drugs at /class/central-nervous-system-stimulant.

What development phase is double blind PR OROS methylphenidate in?

double blind PR OROS methylphenidate is in Phase 3.

What are the side effects of double blind PR OROS methylphenidate?

Common side effects of double blind PR OROS methylphenidate include Nausea, Headache, Insomnia, Dry mouth, Anxiety.

Drug class: All Central nervous system stimulant drugs
Manufacturer: Janssen-Cilag International NV — full pipeline
Therapeutic area: All drugs in Central Nervous System
Indication: Drugs for Attention deficit hyperactivity disorder (ADHD)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing