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# Hypertension Combination Drug Guidance
- URL: https://www.fdaweb.com/hypertension-combination-drug-guidance/
- Published: 2018-01-25T12:00:00.000Z
- Updated: 2026-09-14T23:17:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140599

FDA has published a draft guidance, *Hypertension: Developing Fixed-Dose Combination Drugs for Treatment*, to assist drug sponsors in clinical development of fixed-dose combination drugs for treating hypertension. The [guidance](http://s2027422842.t.en25.com/e/es?s=2027422842&e=44681&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=cd7f755ea2ff420da349457aa36e6e8b&elqaid=2211&elqat=1&ref=fdaweb.com) focuses on development of two-drug combinations of previously approved drugs, although FDA says the general approach is readily applicable to combinations of three or more drugs. It does not address combinations that include unapproved drugs.

“In considering fixed combinations,” the agency says in the document, “FDA recognizes the interest both in **(1)** developing combinations of less than full doses of drugs with distinct mechanisms of action (e.g., a diuretic combined with an angiotensin-converting enzyme inhibitor, an angiotensin-receptor blocker, or a beta blocker) that could be used as initial therapy; and **(2)** providing a range of combinations that allow dose titration to attain adequate blood pressure control.”