Last reviewed 2026-05-25 · How we verify

Zicam (Ionic zinc)

Integrative Medicine Institute · Phase 3 active Small molecule ✓ Verified May 2026

Zicam (Ionic zinc) is a Small molecule drug developed by Integrative Medicine Institute. It is currently in Phase 3 development. Also known as: Homeopathic Zinc gluconate.

Zicam, an ionic zinc product, is a small molecule with a sunscreen/skin protectant mechanism of action. It has been studied in a clinical trial for the treatment of Herpes Simplex Labialis, a condition where it was compared to a placebo.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Zicam (Ionic zinc)
Also known as	Homeopathic Zinc gluconate
Sponsor	Integrative Medicine Institute
Modality	Small molecule
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Zinc for the Treatment of Herpes Simplex Labialis (HSL) (PHASE3)

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:

Zicam (Ionic zinc) CI brief — competitive landscape report
Zicam (Ionic zinc) updates RSS · CI watch RSS
Integrative Medicine Institute portfolio CI

Frequently asked questions about Zicam (Ionic zinc)

What is Zicam (Ionic zinc)?

Zicam (Ionic zinc) is a Small molecule drug developed by Integrative Medicine Institute.

Who makes Zicam (Ionic zinc)?

Zicam (Ionic zinc) is developed by Integrative Medicine Institute (see full Integrative Medicine Institute pipeline at /company/integrative-medicine-institute).

Is Zicam (Ionic zinc) also known as anything else?

Zicam (Ionic zinc) is also known as Homeopathic Zinc gluconate.

What development phase is Zicam (Ionic zinc) in?

Zicam (Ionic zinc) is in Phase 3.

Manufacturer: Integrative Medicine Institute — full pipeline
Also known as: Homeopathic Zinc gluconate

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