Clinical Trials in the US now fill a registry of 604,566 studies on ClinicalTrials.gov, with sites in all 50 states, and the FDA approved 44 novel drugs through September 25, 2026, after 46 in 2025. Only 6.7% of drugs that enter Phase I reach approval, and a single Phase III trial can run 1 to 4 years.
Clinical Trials in the US 2026 – Introduction
Clinical Trials in the US run under one of the most closely watched systems in medicine. Federal law requires many trials to register on ClinicalTrials.gov, and the FDA decides which new drugs reach patients. In 2026, the registry lists 604,566 studies with sites in all 50 states and 226 countries and territories. Sponsors range from large drugmakers to universities and hospital networks. This report pulls the newest verified numbers from the FDA, the National Library of Medicine, and published industry analyses.
The FDA’s Center for Drug Evaluation and Research approved 46 novel drugs in 2025 and cleared 44 more by September 25, 2026. The 2025 approvals rest on pivotal trials that enrolled about 26,000 people. Yet most drug candidates never get that far. Each section below pairs a chart and a table with plain analysis, so you can see how phases, timelines, and participant makeup shape the odds.
Interesting Facts About Clinical Trials in the US 2026
REGISTERED STUDIES ON CLINICALTRIALS.GOV
2000 (launch) | ▏ 1,255
Early 2006 | ██ 24,822
Early 2012 | ████████ 118,020
Jan 2024 | ████████████████████████████████ 477,227
2026 | ████████████████████████████████████████ 604,566
| Fact | 2026 Data |
|---|---|
| Studies registered on ClinicalTrials.gov | 604,566 |
| Countries and territories with study sites | 226 |
| Monthly unique visitors to ClinicalTrials.gov (Dec 2025) | 3.2 million |
| FDA novel drug approvals in 2025 | 46 |
| FDA novel drug approvals in 2026 (through Sept 25) | 44 |
| Phase I drugs that reach approval (2014-2023) | 6.7% |
| 2025 novel approvals that used an expedited program | 72% |
| AI-related trials registered by April 2026 | 8,532 |
Source: ClinicalTrials.gov, National Library of Medicine (NIH); FDA Center for Drug Evaluation and Research; Norstella Citeline; arXiv preprint (July 2026) analyzing ClinicalTrials.gov records.
The registry grew from 1,255 studies at its 2000 launch to 604,566 today. Growth slowed in relative terms, yet the count still rose by about 127,000 studies since January 2024. The site reaches 3.2 million unique visitors a month, and its records cover 226 countries and territories. That makes it the main public window into Clinical Trials in the US.
The FDA numbers show steady output. The agency approved 46 novel drugs in 2025 and 44 by late September 2026. Attrition stays brutal, with a 6.7% approval chance from Phase I. Expedited pathways touched 72% of 2025 approvals. AI-related trials now number 8,532 by a preprint count, a figure that comes from registry records rather than FDA data.
How Many Drugs Did the FDA Approve in 2026? Annual Novel Approvals
FDA NOVEL DRUG APPROVALS BY YEAR
2021 | █████████████████████████ 50
2022 | ███████████████████ 37
2023 | ███████████████████████████ 54
2024 | █████████████████████████ 50
2025 | ███████████████████████ 46
2026 (Sep 25)| ██████████████████████ 44
| Year | Novel Approvals |
|---|---|
| 2021 | 50 |
| 2022 | 37 |
| 2023 | 54 |
| 2024 | 50 |
| 2025 | 46 |
| 2026 (through Sept 25) | 44 |
| 10-year average (2016-2025) | 47 |
Source: U.S. Food and Drug Administration, CDER New Drug Therapy Approvals 2025 (January 2026) and Novel Drug Approvals for 2026 (current as of Sept 25, 2026).
Yearly totals swing within a narrow band. The count fell to 37 in 2022, jumped to 54 in 2023, then settled at 50 in 2024 and 46 in 2025. The 10-year average sits at 47, well above the 38 drugs per year the FDA has averaged since 2007. The 2026 tally of 44 arrived in under nine months, so the year is on pace to top 2025.
The 2025 class split into 34 new molecular entities and 12 biologics. Half of them, 23, carried orphan designation for rare disease. Another 20 (43%) were first-in-class. Add the FDA’s biologics center and the 2025 total reaches 58 novel approvals. Sponsors run the trials behind every one of these approvals under FDA oversight.
FDA Approvals 2026 by Quarter: Novel Drug Approvals Through September
2026 NOVEL DRUG APPROVALS BY QUARTER
Q1 (Jan-Mar) | ██████████ 10
Q2 (Apr-Jun) | █████████████ 13
Q3 (Jul-Sep 25) | █████████████████████ 21
| Period | Novel Approvals |
|---|---|
| Q1 (Jan-Mar) | 10 |
| Q2 (Apr-Jun) | 13 |
| Q3 (Jul-Sept 25) | 21 |
| Total through Sept 25 | 44 |
Source: U.S. Food and Drug Administration, Novel Drug Approvals for 2026 (quarterly totals tallied from the FDA listing, current as of Sept 25, 2026).
The pace accelerated as the year went on. The first quarter produced 10 approvals, starting with a single January action. The second quarter added 13, led by 8 in May alone. The third quarter reached 21 by September 25, the busiest stretch so far. The three quarters sum to the 44 approvals the FDA lists.
Monthly counts explain the shape. January had 1, February 4, March 5, and April 2. May jumped to 8, June fell to 3, July reached 6, August 7, and September 8 by the 25th. Approvals covered obesity, Parkinson’s disease, pancreatic cancer, and rare genetic disorders. Anyone searching FDA approvals 2026 should expect the fourth quarter to add more.
FDA Expedited Approval Programs 2026: Fast Track, Breakthrough and Priority Review
2025 NOVEL APPROVALS BY FDA PROGRAM
Fast track | ████████████████████ 39%
Breakthrough therapy | █████████████████ 33%
Priority review | ███████████████████████ 46%
Accelerated approval | ████████████ 24%
Any expedited program| ████████████████████████████████████ 72%
| Program | Drugs (of 46) | Share |
|---|---|---|
| Fast track | 18 | 39% |
| Breakthrough therapy | 15 | 33% |
| Priority review | 21 | 46% |
| Accelerated approval | 11 | 24% |
| Any expedited program | 33 | 72% |
Source: U.S. Food and Drug Administration, CDER New Drug Therapy Approvals 2025 (January 2026).
Fast track reached 18 drugs (39%) and adds more FDA contact and rolling review. Breakthrough therapy covered 15 (33%) and adds senior-level guidance. Priority review applied to 21 (46%) and targets action in six months instead of ten. Accelerated approval covered 11 (24%) and lets the FDA rely on surrogate endpoints, though sponsors must confirm benefit after approval.
The programs overlap, so the shares do not add up. 33 of 46 drugs (72%) used at least one, which is why so many new drugs reach patients faster than the standard clock allows. For anyone reading about clinical trials in the US, the takeaway is simple. Serious and rare conditions get faster review, and trial design increasingly aims at those pathways.
Clinical Trial Phases 2026: Success Rates by Phase in the US
CHANCE OF ADVANCING, 2014-2023
Phase I to II | ████████████████████████ 47%
Phase II to III | ██████████████ 28%
Phase III to filing | ████████████████████████████ 55%
Filing to approval | ██████████████████████████████████████████████ 92%
Phase I to approval | ███ 6.7%
| Stage | Typical Participants | Advance Rate |
|---|---|---|
| Phase I | 20 to 80 | 47% |
| Phase II | A few dozen to about 300 | 28% |
| Phase III | 300 to 3,000 | 55% |
| Filing to approval | Not applicable | 92% |
| Phase I to approval | Not applicable | 6.7% |
Source: Norstella (Citeline phase transition data, 2014-2023); U.S. Food and Drug Administration, Step 3: Clinical Research; Texas Woman’s University IRB.
Phase II is the choke point. Only 28% of programs pass it, compared with 47% in Phase I and 55% in Phase III. Phase I tests safety in 20 to 80 people. Phase II is the first real test of benefit in patients. Phase III enrolls 300 to 3,000 people and supplies most safety data. Once a sponsor files, 92% of programs reach the market.
Multiply the four rates and you get the 6.7% chance of approval from Phase I. Cancer programs tend to fare worse than the average in published BIO and Informa analyses. Readers who want the disease burden behind those programs can check our cancer statistics in the US report. The lesson for sponsors is blunt: early efficacy data decide most outcomes.
Clinical Trial Timelines 2026: How Long Trials and FDA Review Take
FDA REVIEW GOALS IN MONTHS
Standard review | ████████████████████ 10
Priority review | ████████████ 6
CNPV pilot (upper end) | ████ 2
| Milestone | Timeline or Rate |
|---|---|
| Phase II length | Several months to 2 years |
| Phase III length | 1 to 4 years |
| Standard review goal | 10 months |
| Priority review goal | 6 months |
| CNPV pilot review goal | 1 to 2 months |
| PDUFA goals met (2025) | 96% (44 of 46) |
| First-cycle approvals (2025) | 85% (39 of 46) |
Source: U.S. Food and Drug Administration, CDER New Drug Therapy Approvals 2025 (January 2026); Texas Woman’s University IRB, Clinical Trials Phases.
Trial length varies by phase. Phase II runs from several months to 2 years. Phase III runs 1 to 4 years. After filing, the FDA aims to act in 10 months on a standard review and 6 months on a priority review. The new Commissioner’s National Priority Voucher pilot targets 1 to 2 months. The chart shows the upper end of that range.
The FDA hit its review goal dates for 44 of 46 novel drugs (96%) in 2025. It approved 39 (85%) on the first review cycle, so few applications needed a second round. Speed matters most when strains change quickly, as our new COVID variant statistics in the US report shows. Predictable timelines help sponsors plan clinical trials in the US with fewer surprises.
Who Joins Clinical Trials in the US 2026: Sex, Age and U.S. Enrollment
U.S. SHARE OF PIVOTAL TRIAL PARTICIPANTS, 2025 APPROVALS
Heart, blood, kidney, endocrine | ████████████████████ 20%
Autoimmune, inflammatory, lung | ████████████████████████ 24%
Cancers | ████████████████████ 20%
| Therapeutic Area | Female | Age 65+ | U.S. Participants |
|---|---|---|---|
| Heart, blood, kidney and endocrine | 45% | 31% | 20% |
| Autoimmune, inflammatory and lung | 55% | 36% | 24% |
| Cancers | 36% | 26% | 20% |
Source: U.S. Food and Drug Administration, CDER Drug Trials Snapshots Summary Report 2025.
The 26,000 people in the 2025 pivotal trials did not sit evenly across groups. Women made up 55% of autoimmune, inflammatory, and lung trials but only 36% of cancer trials. Adults aged 65 and older were 36% of autoimmune and lung trials, 31% of heart, blood, kidney, and endocrine trials, and 26% of cancer trials. The female figures exclude sex-specific drugs.
Geography stands out. Only 20% of participants in heart, blood, kidney, and endocrine trials lived in the United States, and the cancer share was also 20%. Autoimmune and lung trials reached 24%. The rest enrolled overseas. Every pivotal trial ran at multiple sites, and most spanned several countries. That matters for Clinical Trials in the US, because results must still apply to American patients.
Clinical Trial Diversity 2026: Race and Ethnicity in FDA Approval Trials
BLACK PARTICIPANTS IN SELECTED 2025 U.S.-ONLY TRIALS
Journavx | ████████████████████████ 24%
Tryptyr | ██████████████ 14%
Gomekli | ██████████████ 14%
Modeyso | █████████ 9%
Vizz | █████ 5%
| Drug (2025 Approval) | Total N | White | Black | Hispanic |
|---|---|---|---|---|
| Journavx | 2,447 | 72% | 24% | 35% |
| Tryptyr | 931 | 76% | 14% | 12% |
| Vizz | 698 | 88% | 5% | 25% |
| Modeyso | 376 | 74% | 9% | 13% |
| Gomekli | 114 | 75% | 14% | 8% |
Source: U.S. Food and Drug Administration, CDER Drug Trials Snapshots Summary Report 2025.
All five trials enrolled 100% U.S. participants, which makes them useful for judging domestic representation. Total N shows trial size, from 114 for Gomekli to 2,447 for Journavx. White participants ranged from 72% to 88%. Black participation ran from 5% in Vizz to 24% in Journavx. Hispanic participation, counted separately as ethnicity, ranged from 8% to 35%.
Across all 2025 programs, White participants topped 50% in most trials. Black participation ranged from 0% to 55%, and Hispanic participation from 0% to 36%. Gaps like these also appear outside trials. Our COVID-19 statistics in the US report tracks vaccination by group. The FDA publishes these Snapshots so patients and doctors can see who was actually studied.
Clinical Trials in the US 2026 FAQ
How many clinical trials are there in the US in 2026?
ClinicalTrials.gov lists 604,566 studies with locations in all 50 states and 226 countries and territories. That headline total is global. For a US-only count, filter the registry by location and recruitment status.
How many drugs has the FDA approved in 2026?
The FDA approved 44 novel drugs through September 25, 2026. That compares with 46 for all of 2025 and 50 in 2024.
How long do clinical trials take in the US in 2026?
Phase II lasts from several months to 2 years. Phase III lasts 1 to 4 years. FDA review then targets 10 months for standard applications and 6 months for priority ones.
What percentage of clinical trials succeed in 2026?
Phase I advances 47% of the time, Phase II 28%, and Phase III 55%. After filing, 92% of programs gain approval. Overall, 6.7% of Phase I drugs reach the market.
How many people take part in US clinical trials in 2026?
The pivotal trials behind the FDA’s 2025 approvals enrolled about 26,000 people. Only 20% to 24% of them, by therapeutic area, lived in the United States.
What are the four phases of clinical trials in 2026?
Phase I tests safety in 20 to 80 people. Phase II tests benefit in a few dozen to about 300 patients. Phase III enrolls 300 to 3,000. Phase IV tracks safety after approval.
Where can I find clinical trials near me in 2026?
Search ClinicalTrials.gov by condition and location. The site draws 3.2 million unique visitors a month. FDA Drug Trials Snapshots show who joined the trials behind newly approved drugs.
Are AI clinical trials growing in 2026?
A preprint count found 8,532 AI-related trials registered by the end of April 2026. About 793 of them registered in 2026 alone, and the year was not over.
Disclaimer: This research report is compiled from publicly available sources. While reasonable efforts have been made to ensure accuracy, no representation or warranty, express or implied, is given as to the completeness or reliability of the information. We accept no liability for any errors, omissions, losses, or damages of any kind arising from the use of this report.