A Medicine's Path to Patients

Medicine development is a cycle of continuous learning. On average, bringing a new medicine to market takes 10-15 years of research and $2.6 billion. Only about 1 in 10 medicines that enter clinical trials ultimately make it to market.

Click to explore each phase of the drug development cycle

Drug Development Cycle

~10-15 years,
$2.6 billion

Basic Research

Researchers explore how diseases interact with the body and identify potential biological targets for treatment.

2-3 years

Did you know?

The path to new medicines begins long before a drug exists. A foundation of public-private partnerships and years of fundamental research into how diseases form lays the groundwork for the breakthroughs that follow.

Discovery

Researchers screen thousands of chemical or biological compounds to identify promising candidates that could eventually be developed for safe and effective treatments.

2-3 years

Did you know?

The disease targets researchers test new drugs on are dynamic, constantly moving and changing shape inside the body. This means scientists aren’t just fitting a key into a lock, they’re trying to hit a moving target at a molecular scale.

Pre-Clinical Research

Researchers test potential medicine candidates in studies to evaluate toxicity and decide whether to test the drug candidate in people.

2-3 years

Did you know?

Before clinical trials, getting a new medicine right takes more than finding the right target. Researchers study how a drug is absorbed, distributed, metabolized and eliminated, ensuring it does the right job safely.

Clinical Trials

Researchers test medicine candidates on people in well-documented and well-controlled studies, moving through Phase 1 (safety and dosage), Phase 2 (efficacy and side effects) and Phase 3 (large-scale efficacy, safety and monitoring for side effects).

4-7 years

Did you know?

Less than 12% of medicine candidates that enter clinical trials are eventually approved by the FDA.

Patient impact

Patients participating in clinical trials often gain early access to potential innovative treatments, while helping generate data that can transform care for thousands or even millions of other patients.

FDA Review & Approval

Data from pre-clinical research and clinical trials are submitted to the FDA for rigorous evaluation of safety, efficacy and manufacturing quality before a medicine can be approved.

6-12 months

Patient impact

Patients now have access to new safe and effective treatments — offering improved quality of life, better disease management and cures, and renewed hope for the future.

Post-Approval Surveillance

Even after approval, researchers and regulators closely evaluate medicines for potential safety issues and to assess effectiveness in real-world use.

Ongoing

Patient impact

Continuous monitoring in real-world use helps ensure safe and effective treatments for patients and facilitates updates to labeling with new information if needed.

Post-Approval R&D

FDA approval isn’t always the finish line. Researchers may continue to explore new uses, formulations and improvements for FDA-approved medicines to make critical advances to treatment options and better meet the needs of patients.

Ongoing

Did you know?

Over half of new uses for cardiovascular medicines are identified after the initial FDA approval.

Patient impact

Patients benefit from improved formulations — easier dosing, fewer side effects or new treatment options for related conditions.

While a medicine is in development, companies work in parallel to build the manufacturing capacity needed to bring it to patients. As the new medicine moves closer to approval, manufacturers transition from producing small clinical trial batches to safely scaling up for mass production and distribution to patients.

This process requires robust supply chains, production capacity, quality controls and regulatory approvals for new manufacturing facilities. The FDA helps ensure medicines made in the United States meet rigorous safety and efficacy standards and follow Current Good Manufacturing Practices regulations.

Protecting and incentivizing R&D every step of the way is critical to supporting scientific discovery and ensuring new innovations reach patients.

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