Digital combination drugs

Medicines and AI
New possibilities
for personalized care

Combining the action of medicines with personalized
digital treatment to develop digital combination drugs.

Development concept combining medication and Dr.SAM
Dr.SAM

Record through conversation. Review changes at a glance

Dr.SAM conversations follow symptoms, daily habits and changes after medication.
Accumulated records are organized into a report.

Development concept · Example screens

01 / 03

Conversations about everyday changes

Ask about symptoms and habits, then follow changes after medication.

Dr.SAMConversations about everyday changes
  1. Patient

    I have a bad headache today.

  2. Dr.SAM

    How did you sleep last night?

  3. Patient

    I was up late working.

  4. Dr.SAM

    Lack of sleep can cause headaches — I’ll note that.

  5. Patient

    I took my prescription for the headache.

  6. Dr.SAM

    It’s been two hours since your dose — how are you feeling now?

02 / 03

Patient records from the conversation

Organize symptoms, habits and medication records from the conversation.

Dr.SAM

Patient records from the conversation

01
Symptoms
I have a bad headache today.
02
Daily habits
I was up late working.
03
Medication record
I took my prescription for the headache.

Changes after medication are checked in the follow-up conversation.

03 / 03

A report of treatment progress

Review symptom trends and changes after medication through accumulated records.

Sample eight-week health report: symptom trends and medication records
Dr.SAMConversations about everyday changes
  1. Patient

    I have a bad headache today.

  2. Dr.SAM

    How did you sleep last night?

  3. Patient

    I was up late working.

  4. Dr.SAM

    Lack of sleep can cause headaches — I’ll note that.

  5. Patient

    I took my prescription for the headache.

  6. Dr.SAM

    It’s been two hours since your dose — how are you feeling now?

Global regulatory landscape

The regulatory foundation for digitally augmented therapies

For treatments that combine medicines and digital technology,
Korea has established a legal framework, while the US is outlining its regulatory approach.

KoreaLaw in effect

Digital Medical Products Act

The Act defines digital combination drugs as a product category and establishes a framework for their development, authorization and evaluation.

Read the Act
United StatesDraft guidance

FDA PDURS

Prescription Drug Use-Related Software

The FDA draft describes how drug-labeling authorities would apply to certain outputs of software used with prescription drugs.

Read FDA draft guidance
PHARMA × DrugOS™

Digital drug partnerships

From differentiating existing medicines to building new pipelines,
partner with DrugOS™.

Partnership enquiries
Pharmaceutical partnerMedicines & clinical expertise
DrugOS™Patient understanding & precision therapy
What we develop togetherDifferentiated digital combination drugs
Global collaboration examples
Development collaboration

Remepy × Merck

Exploring Hybrid Drugs that combine medicines with digital treatment protocols

Official announcement
FDA authorized · Launched

Otsuka × Click

Rejoyn, a prescription digital therapeutic used alongside antidepressant treatment

Official announcement