Last reviewed 2026-04-19 · How we verify

Depo-Provera CI

FHI 360 · Phase 1 active Small molecule

Depo-Provera CI is a Small molecule drug developed by FHI 360. It is currently in Phase 1 development. Also known as: Depo Provera® Contraceptive Injection.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Depo-Provera CI
Also known as	Depo Provera® Contraceptive Injection
Sponsor	FHI 360
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Depo-Provera CI CI brief — competitive landscape report
Depo-Provera CI updates RSS · CI watch RSS
FHI 360 portfolio CI

Frequently asked questions about Depo-Provera CI

What is Depo-Provera CI?

Depo-Provera CI is a Small molecule drug developed by FHI 360.

Who makes Depo-Provera CI?

Depo-Provera CI is developed by FHI 360 (see full FHI 360 pipeline at /company/fhi-360).

Is Depo-Provera CI also known as anything else?

Depo-Provera CI is also known as Depo Provera® Contraceptive Injection.

What development phase is Depo-Provera CI in?

Depo-Provera CI is in Phase 1.

Manufacturer: FHI 360 — full pipeline
Also known as: Depo Provera® Contraceptive Injection

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