Clinical development regulatory approval rate

STO-REC-STATV2J1XAT2 National
12%
estimate

United States · end of 2025

Clinical development regulatory approval rate in United States stood at 12% at end of 2025 (PhRMA).

Original source
Publisher
PhRMA
Authority tier
T2 National
Locator
Progress toward New Medicines and Vaccines
Retrieved
17 Sep 2026
Status
Verified

What the source says

Only 12% of new molecular entities that enter clinical trials eventually receive U.S. Food and Drug Administration (FDA) approval.

Verbatim extraction verified: The figure 12% is directly attested in the quoted passage (Progress toward New Medicines and Vaccines).

The figure above was extracted from this passage. If it does not match, the extraction is wrong and we want to know.

Cite this figure

Published under CC BY 4.0. Attribute the original publisher; the citations below do that for you and link to this permanent record.

APA
PhRMA. (2025). Research & Development. Retrieved September 17, 2026, from https://phrma.org/policy-issues/research-development. Via StatOrigin, https://statorigin.org/stat/stat_V2J1XACMRQE968NSWN5E8TT1Q5
MLA
PhRMA. "Research & Development." 2025, https://phrma.org/policy-issues/research-development. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_V2J1XACMRQE968NSWN5E8TT1Q5.
Chicago
PhRMA. "Research & Development." 2025. https://phrma.org/policy-issues/research-development. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_V2J1XACMRQE968NSWN5E8TT1Q5.
BibTeX
@misc{phrma2025clinical8tt1q5, author = {{PhRMA}}, title = {Research \& Development}, year = {2025}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_V2J1XACMRQE968NSWN5E8TT1Q5}, note = {Original source: https://phrma.org/policy-issues/research-development. Accessed September 17, 2026.} }

Provenance and verification

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Chain of Custody · Verification Audit
Record: STO-REC-STATV2J1XA T2 National

Primary Source

Publisher
PhRMA · homepage ↗
Authority tier
Tier 2 · National Official
Report
Research & Development
Type
Press release
Published
Locator
Progress toward New Medicines and Vaccines
Retrieved
17 September 2026
Link status
Reachable (HTTP 200)
Report licence
See source

Verification & Integrity

Audit status
Verified
Review protocol
Editorial review
Checked on
17 September 2026
Last revision
17 September 2026
Archival URI
/stat/stat_V2J1XACMRQE968NSWN5E8TT1Q5