Last reviewed 2026-05-28 · How we verify

Silfamin

Dexa Medica Group · Phase 2 active Small molecule ✓ Verified May 2026

Silfamin is a Small molecule drug developed by Dexa Medica Group. It is currently in Phase 2 development. Also known as: Herbacold.

Silfamin is a substance being studied for its efficacy and safety in treating the common cold, with or without sore throat. Clinical trials have compared Silfamin to a placebo to determine its effectiveness in these conditions.

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	Silfamin
Also known as	Herbacold
Sponsor	Dexa Medica Group
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

Efficacy and Safety of Silfamin for Common Cold (PHASE2)

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:

Silfamin CI brief — competitive landscape report
Silfamin updates RSS · CI watch RSS
Dexa Medica Group portfolio CI

Frequently asked questions about Silfamin

What is Silfamin?

Silfamin is a Small molecule drug developed by Dexa Medica Group.

Who makes Silfamin?

Silfamin is developed by Dexa Medica Group (see full Dexa Medica Group pipeline at /company/dexa-medica-group).

Is Silfamin also known as anything else?

Silfamin is also known as Herbacold.

What development phase is Silfamin in?

Silfamin is in Phase 2.

Manufacturer: Dexa Medica Group — full pipeline
Therapeutic area: All drugs in Other
Also known as: Herbacold

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