Back to discover
Drug

Modafinil

Regulatory activity · MHRA
Emerging researchLate-stage developmentSteady momentum
Also known as 2-((diphenylmethyl)sulfinyl)acetamide, Provigil, (-)-modafinil, Modafinilo+1 more

2-((diphenylmethyl)sulfinyl)acetamide, Provigil, (-)-modafinil, Modafinilo, Modafinilum.

RxNorm30125ChEMBLCHEMBL1373UNIIR3UK8X3U3D
4
Research papers
11
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Cognitive Strategies in Early Psychosis 2

Clinical trial2026-07-10Results expected Q2 2030 · ClinicalTrials.gov

Investigation of Locus Coeruleus Function in Sustained Attention

Clinical trial2026-06-18Results expected Q4 2026 · ClinicalTrials.gov

Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)

Clinical trial2026-05-22Results expected Q1 2027 · ClinicalTrials.gov

Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting

Clinical trial2026-05-06Results expected Q2 2028 · ClinicalTrials.gov

RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Clinical trial2026-04-20Completed · ClinicalTrials.gov

Drug Safety Update: Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy

Regulatory2020-11-16MHRA

Drug Safety Update: Modafinil (Provigil): now restricted to narcolepsy

Regulatory2014-12-11MHRA

Drug Safety Update: Modafinil: restricted use recommended

Regulatory2014-12-11MHRA

A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone.

Research2014-01-03Drug and alcohol dependence

Modafinil for the treatment of methamphetamine dependence.

Research2011-08-12Drug and alcohol dependence

Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study.

Research2010-05-04The Journal of clinical psychiatry

Randomized, double-blind, placebo-controlled trial of modafinil for the treatment of methamphetamine dependence.

Research2010-01-25Drug and alcohol dependence

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Modafinil
Aliases & brands
2-((diphenylmethyl)sulfinyl)acetamideProvigil(-)-modafinilModafiniloModafinilum
RxNorm CUI
30125
ChEMBL ID
CHEMBL1373
UNII
R3UK8X3U3D
Regulatory jurisdictions
mhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
3
mhraMedicines and Healthcare products Regulatory Agency· 3 events
2020-11-16Safety communicationSafety
Drug Safety Update: Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Modafinil (Provigil): now restricted to narcolepsy
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Modafinil: restricted use recommended
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

139 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
139
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
9
Recruiting
69
Late-stage (III+)
91
Completed
37
Discontinued
PHASE DISTRIBUTIONn = 139
Early Phase 14Phase 122Phase 1 / 24Phase 240Phase 2 / 33Phase 326Phase 421Phase N / A19

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Investigation of Locus Coeruleus Function in Sustained Attention

RecruitingPH IVUniversity of California, Davisn=402026

A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis

CompletedPH IVUniversity of Michigann=3432021

Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms

CompletedPH IVUniversity of California, San Diegon=232021

A Randomized, Double Blind, Placebo Controlled Evaluation of Modafinil vs Placebo for the Treatment of General Anesthesia Related Delayed Emergence in Patients With the Diagnosis of Obstructive Sleep Apnea

TerminatedPH IVMilton S. Hershey Medical Centern=1052018

Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

CompletedPH IVIcahn School of Medicine at Mount Sinain=182017

Recent completions

Trials that read out recently, adding to the completed evidence base.

RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

CompletedPH IIDuke Universityn=3612026

RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

CompletedPH IIDuke Universityn=8302025

Study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery

CompletedN/AAin Shams Universityn=202025

A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control

CompletedPH IMerck Sharp & Dohme LLCn=182024

A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants

CompletedPH IMerck Sharp & Dohme LLCn=122023

An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

CompletedPH IPfizern=562023

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102014
Major research themes1
Methamphetamine2
Journals, researchers & institutions
Top journals
  • Drug and alcohol dependence3
  • The Journal of clinical psychiatry1
Leading researchers
  • Anderson AL1
  • Beresford T1
  • Biswas K1
  • Campbell J1
  • Cederblom L1
  • Chiang N1
  • Elkashef AM1
  • Grabowski J1
Leading institutions
free-text, unnormalised
  • Baylor College of Medicine1
  • Center for Clinical Research & Evidence-Based Medicine1
  • College of Physicians and Surgeons1
  • David Geffen School of Medicine at UCLA1
  • Medical School1
  • National Institute on Drug Abuse1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.