Last reviewed 2026-05-24 · How we verify

blue m gel

Faculty of Dental Medicine for Girls · Phase 1 active Small molecule ✓ Verified May 2026

blue m gel is a Small molecule drug developed by Faculty of Dental Medicine for Girls. It is currently in Phase 1 development.

Blue M gel is a small molecule with a reducing agent mechanism. It is being studied in clinical trials for various oral conditions, including cleft lip, gingival pigmentation, oral lichen planus, and erosive lichen planus, as part of a study on topical active oxygen therapy.

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	blue m gel
Sponsor	Faculty of Dental Medicine for Girls
Modality	Small molecule
Phase	Phase 1

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:

blue m gel CI brief — competitive landscape report
blue m gel updates RSS · CI watch RSS
Faculty of Dental Medicine for Girls portfolio CI

Frequently asked questions about blue m gel

What is blue m gel?

blue m gel is a Small molecule drug developed by Faculty of Dental Medicine for Girls.

Who makes blue m gel?

blue m gel is developed by Faculty of Dental Medicine for Girls (see full Faculty of Dental Medicine for Girls pipeline at /company/faculty-of-dental-medicine-for-girls).

What development phase is blue m gel in?

blue m gel is in Phase 1.

Manufacturer: Faculty of Dental Medicine for Girls — full pipeline

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