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Sayana Press

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 14, 2025

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

Clinical trial landscape

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 used for?

Sayana Press is an investigational small molecule being studied for use in healthy individuals. It is a subcutaneous injection formulation, and the clinical trial focuses on healthy female volunteers. The drug is currently in Phase 1 clinical development.

Who makes Sayana Press?

Sayana Press is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's administration and effects.

What phase is Sayana Press in?

Sayana Press is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacokinetics.

What clinical trials is Sayana Press in?

Sayana Press has one completed clinical trial, NCT04893798, which compared subcutaneous injection of Sayana Press in the upper arm versus the anterior thigh and abdomen. The trial enrolled 67 healthy female participants in Belgium and was actively controlled.

How is Sayana Press administered?

Sayana Press is administered as a subcutaneous injection. The completed clinical trial evaluated injection into the upper arm, anterior thigh, and abdomen to compare these administration sites. The study enrolled healthy female volunteers aged 18 years and older.