Intrarosa

(Prasterone)

ApprovedSmall molecule

Alnylam Pharmaceuticals

Intrarosa is one of 133 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

132

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Recurrent Urinary Tract InfectionsActive, not recruiting

DyspareuniaActive, not recruiting

AtrophyActive, not recruiting

Breast CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

Recurrent Urinary Tract InfectionsPhase 3

Active, not recruiting

DyspareuniaApproved

Active, not recruiting

AtrophyPhase 3

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Intrarosa

Alnylam Pharmaceuticals

Approved

2 2

Trodelvy

Gilead

Preclinical

37 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Megace

Bristol-Myers Squibb

Preclinical

4 5

MS Contin

Merck & Co.

Preclinical

2 6

Zolymbus

AbbVie

Preclinical

1 7

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 8

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 9

Chirocaine

PPurdue Pharma LP

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Rectal Cancer

NCT07407647

Q1 2027

Phase 3Not yet recruiting

Breast Cancer

NCT06611514

Clinical

Trials by Indication[1]

Breast Cancer2 trials

Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Withdrawn·EEndoCeutics Inc.·Phase 3·NCT03740945

Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

Not yet recruiting·EEuropean Institute of Oncology·Phase 3·NCT06611514·95 enrolled

Dyspareunia1 trial

Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

Completed·SSan Diego Sexual Medicine·Phase 4·NCT03568604·18 enrolled

Multiple Myeloma1 trial

Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT00006219

Cancer1 trial

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01376349·464 enrolled

Atrophy1 trial

Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain

Unknown status·—·Phase 3·NCT04898556·50 enrolled

5 more indications

Glucocorticoids1 trial

To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

Unknown status·GGenelabs Technologies·Phase 3·NCT00053560·155 enrolled

Systemic Lupus Erythematosus1 trial

GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Completed·GGenelabs Technologies·Phase 3·NCT00082511·114 enrolled

Menopause1 trial

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Completed·EEndoCeutics Inc.·Phase 3·NCT02013544·558 enrolled

Rectal Cancer1 trial

Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT07407647·25 enrolled

Recurrent urinary tract infections1 trial

Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women

Withdrawn·OOlivia Cardenas-Trowers, M.D.·Phase 3·NCT03854396

Regulatory

FDA Approval Timeline[4]

Nov 16, 2016

INTRAROSA

NDA NDA208470

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Prasterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Prasterone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Prasterone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208470). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Intrarosa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Alnylam Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Aug 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8629129Aug 7, 2028

8957054Jan 8, 2030

8268806Mar 19, 2031

Intrarosa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer2 trials

Dyspareunia1 trial

Multiple Myeloma1 trial

Cancer1 trial

Atrophy1 trial

Glucocorticoids1 trial

Systemic Lupus Erythematosus1 trial

Menopause1 trial

Rectal Cancer1 trial

Recurrent urinary tract infections1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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