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Sayana Press

Phase 4

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Aug 14, 2025

Sayana Press development status

Highest phase Phase 4 (NCT03034057)
Phase scored for PFEPhase 1
Registered trials 2 across 1 sponsor since Jan 2017

Sayana Press target and mechanism

ModalitySmall molecule

Also known as Medroxyprogesterone

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Sayana Press clinical trials

Sayana Press · 1 trial · 1 indication

Phase 1 1
NCT04893798A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and AbdomenHealthy
COMPLETED67 Analytics
PHASE1COMPLETED
A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Trough Concentration (Ctrough) of Medroxyprogesterone
Day 92 post dose
Area under the curve from time zero to end of dosing interval (AUCtau)
pre-dose, up to 92 days post dose
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone
pre-dose, up to 92 days post dose

Secondary Endpoints

Serum Progesterone Level
pre-dose, up to 99 days post dose
Serum Estradiol Level
pre-dose, up tp 99 days post dose
Serum Luteinizing Hormone (LH) Level
pre-dose, up to 99 days post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sayana Press, Upper Arm injectionEXPERIMENTALSayana Press, administered subcutaneously into upper arm
Sayana Press, anterior thighACTIVE_COMPARATORSayana Press, administered subcutaneously into anterior thigh
Sayana Press, abdomenACTIVE_COMPARATORSayana Press, administered subcutaneously into abdomen

Interventions

NameTypeDescription
Sayana PressCOMBINATION_PRODUCTSayana Press is a drug-device combination and is considered a medical product in the EU.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Pre-menopausal female participants, 18 to 45 years of age, inclusive, at the time of signing the ICD who are at low risk of pregnancy * Participants who have a regular menstrual cycle (between 21 and 42 days in length). * No previous injection of depot MPA for 1 year prior to ...

Countries:Belgium
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Frequently asked questions about Sayana Press

What is Sayana Press?

Sayana Press is an injectable small molecule developed by Pfizer, Inc. (ticker: PFE). It has been studied in a Phase 1 clinical trial in healthy female volunteers. The specific therapeutic indication for Sayana Press is undisclosed.

Who makes Sayana Press?

Sayana Press is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer responsible for the clinical testing of Sayana Press.

What phase is Sayana Press in?

Sayana Press is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in further trials. It is an investigational product and has not been approved by the FDA.

What clinical trials is Sayana Press in?

Sayana Press has been evaluated in one completed Phase 1 trial, NCT04893798. The study compared subcutaneous injection of Sayana Press in the upper arm versus the anterior thigh and abdomen. It enrolled 67 healthy female volunteers aged 18 years and older in Belgium.

How was Sayana Press administered in its clinical trial?

In the completed Phase 1 trial NCT04893798, Sayana Press was given as a subcutaneous injection. The study compared administration in the upper arm versus the anterior thigh and abdomen. The trial was active-controlled, randomized, and enrolled 67 healthy female volunteers in Belgium.