What's the most recent regulatory action in Premenstrual dysphoric disorder?

Most recent: Estring — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Premenstrual dysphoric disorder — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Premenstrual dysphoric disorder (disease) competitive landscape: 8 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

8 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Premenstrual dysphoric disorder, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Slynd	DROSPIRENONE	Exeltis Usa Inc	Progestin	Mineralocorticoid receptor	2019-01-01
Zoloft	sertraline	Pfizer Inc.	SSRI (Selective serotonin reuptake inhibitor)	Cytochrome P450 2C19, Melanocortin receptor 5, 5-hydroxytryptamine receptor 2A	1991-12-30
Prozac	fluoxetine	Eli Lilly and Company	Selective Serotonin Reuptake Inhibitor (SSRI)	Serotonin reuptake transporter	1987-12-29
Estrace	ESTRADIOL	Pfizer	Estrogen	Estrogen receptor	1975-01-01
Ortho-Novum 10/11-21	Ethinylestradiol	Merck & Co.	Estrogen	Estrogen receptor	1943-01-01
Metafolin	Metafolin	University of California, San Diego		Thymidylate synthase
Sertralin	Sertralin	Poznan University of Medical Sciences		Cytochrome P450 2C19, Melanocortin receptor 5, 5-hydroxytryptamine receptor 2A
Prozac	Prozac	RenJi Hospital		Equilibrative nucleoside transporter 4, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2A

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-05-11 — Estring · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Pfizer Inc. · 2 drugs in Premenstrual dysphoric disorder
Exeltis Usa Inc · 1 drug in Premenstrual dysphoric disorder
Merck & Co. · 1 drug in Premenstrual dysphoric disorder
Pfizer · 1 drug in Premenstrual dysphoric disorder
Poznan University of Medical Sciences · 1 drug in Premenstrual dysphoric disorder
RenJi Hospital · 1 drug in Premenstrual dysphoric disorder
Eli Lilly and Company · 1 drug in Premenstrual dysphoric disorder
University of California, San Diego · 1 drug in Premenstrual dysphoric disorder

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Every new regulatory action, PDUFA date, or trial completion in Premenstrual dysphoric disorder:

Cite this brief

Drug Landscape (2026). Premenstrual dysphoric disorder — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/premenstrual-dysphoric-disorder. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing