Last reviewed 2026-05-30 · How we verify

ORADUR®-Methylphenidate

Orient Pharma Co., Ltd. · Phase 3 active Small molecule Under review Quality 0/100

ORADUR®-Methylphenidate is a Sympathomimetic amine; central nervous system stimulant Small molecule drug developed by Orient Pharma Co., Ltd.. It is currently in Phase 3 development for Attention deficit hyperactivity disorder (ADHD) in children and adults.

ORADUR-Methylphenidate is an extended-release formulation of methylphenidate that inhibits the reuptake of dopamine and norepinephrine in the central nervous system.

ORADUR-Methylphenidate is a small molecule that inhibits the sodium-dependent dopamine transporter, classified as a dopamine transporter inhibitor. It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents, as demonstrated in clinical trials.

Likelihood of approval

55.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	ORADUR®-Methylphenidate
Sponsor	Orient Pharma Co., Ltd.
Drug class	Sympathomimetic amine; central nervous system stimulant
Target	Dopamine transporter (DAT); Norepinephrine transporter (NET)
Modality	Small molecule
Therapeutic area	Neurology / Psychiatry
Phase	Phase 3

Mechanism of action

Methylphenidate blocks the reuptake transporters for dopamine and norepinephrine, increasing their synaptic concentrations and enhancing neurotransmission in the brain. The ORADUR formulation provides sustained drug release over an extended period, allowing for once-daily dosing and more stable therapeutic levels throughout the day. This mechanism improves attention, focus, and impulse control in patients with attention deficit hyperactivity disorder (ADHD).

Approved indications

Attention deficit hyperactivity disorder (ADHD) in children and adults

Common side effects

Insomnia
Decreased appetite
Headache
Nervousness or anxiety
Tachycardia
Elevated blood pressure

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:

ORADUR®-Methylphenidate CI brief — competitive landscape report
ORADUR®-Methylphenidate updates RSS · CI watch RSS
Orient Pharma Co., Ltd. portfolio CI

Frequently asked questions about ORADUR®-Methylphenidate

What is ORADUR®-Methylphenidate?

ORADUR®-Methylphenidate is a Sympathomimetic amine; central nervous system stimulant drug developed by Orient Pharma Co., Ltd., indicated for Attention deficit hyperactivity disorder (ADHD) in children and adults.

How does ORADUR®-Methylphenidate work?

ORADUR-Methylphenidate is an extended-release formulation of methylphenidate that inhibits the reuptake of dopamine and norepinephrine in the central nervous system.

What is ORADUR®-Methylphenidate used for?

ORADUR®-Methylphenidate is indicated for Attention deficit hyperactivity disorder (ADHD) in children and adults.

Who makes ORADUR®-Methylphenidate?

ORADUR®-Methylphenidate is developed by Orient Pharma Co., Ltd. (see full Orient Pharma Co., Ltd. pipeline at /company/orient-pharma-co-ltd).

What drug class is ORADUR®-Methylphenidate in?

ORADUR®-Methylphenidate belongs to the Sympathomimetic amine; central nervous system stimulant class. See all Sympathomimetic amine; central nervous system stimulant drugs at /class/sympathomimetic-amine-central-nervous-system-stimulant.

What development phase is ORADUR®-Methylphenidate in?

ORADUR®-Methylphenidate is in Phase 3.

What are the side effects of ORADUR®-Methylphenidate?

Common side effects of ORADUR®-Methylphenidate include Insomnia, Decreased appetite, Headache, Nervousness or anxiety, Tachycardia, Elevated blood pressure.

What does ORADUR®-Methylphenidate target?

ORADUR®-Methylphenidate targets Dopamine transporter (DAT); Norepinephrine transporter (NET) and is a Sympathomimetic amine; central nervous system stimulant.

Drug class: All Sympathomimetic amine; central nervous system stimulant drugs
Target: All drugs targeting Dopamine transporter (DAT); Norepinephrine transporter (NET)
Manufacturer: Orient Pharma Co., Ltd. — full pipeline
Therapeutic area: All drugs in Neurology / Psychiatry
Indication: Drugs for Attention deficit hyperactivity disorder (ADHD) in children and adults

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