Last reviewed 2026-04-19 · How we verify

Levonorgestrel 0.15 milligram

InnovaGyn, Inc. · Phase 2 active Small molecule

Levonorgestrel 0.15 milligram is a Small molecule drug developed by InnovaGyn, Inc.. It is currently in Phase 2 development. Also known as: Plan B one Step.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Levonorgestrel 0.15 milligram
Also known as	Plan B one Step
Sponsor	InnovaGyn, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Levonorgestrel 0.15 milligram CI brief — competitive landscape report
Levonorgestrel 0.15 milligram updates RSS · CI watch RSS
InnovaGyn, Inc. portfolio CI

Frequently asked questions about Levonorgestrel 0.15 milligram

What is Levonorgestrel 0.15 milligram?

Levonorgestrel 0.15 milligram is a Small molecule drug developed by InnovaGyn, Inc..

Who makes Levonorgestrel 0.15 milligram?

Levonorgestrel 0.15 milligram is developed by InnovaGyn, Inc. (see full InnovaGyn, Inc. pipeline at /company/innovagyn-inc).

Is Levonorgestrel 0.15 milligram also known as anything else?

Levonorgestrel 0.15 milligram is also known as Plan B one Step.

What development phase is Levonorgestrel 0.15 milligram in?

Levonorgestrel 0.15 milligram is in Phase 2.

Manufacturer: InnovaGyn, Inc. — full pipeline
Also known as: Plan B one Step

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