Last reviewed 2026-05-22 · How we verify

Zesteem

Renovo · Phase 2 active Small molecule ✓ Verified May 2026

Zesteem is a Small molecule drug developed by Renovo. It is currently in Phase 2 development. Also known as: 17β-Estradiol, RN1002.

Zesteem, a medication containing estradiol, has been studied in clinical trials for its potential to accelerate healing in various conditions, including burns, trauma, varicose ulcers, cicatrix, and wound-healing. Specifically, a double-blind, placebo-controlled trial investigated the efficacy of Zesteem in accelerating the healing of split thickness skin graft donor sites.

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	Zesteem
Also known as	17β-Estradiol, RN1002
Sponsor	Renovo
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

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:

Zesteem CI brief — competitive landscape report
Zesteem updates RSS · CI watch RSS
Renovo portfolio CI

Frequently asked questions about Zesteem

What is Zesteem?

Zesteem is a Small molecule drug developed by Renovo.

Who makes Zesteem?

Zesteem is developed by Renovo (see full Renovo pipeline at /company/renovo).

Is Zesteem also known as anything else?

Zesteem is also known as 17β-Estradiol, RN1002.

What development phase is Zesteem in?

Zesteem is in Phase 2.

Manufacturer: Renovo — full pipeline
Therapeutic area: All drugs in Other
Also known as: 17β-Estradiol, RN1002

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