Topical berberine · Made in Riyadh

Science you apply.

A Saudi-made topical berberine massage gel, manufactured in a licensed pharmaceutical facility and notified with the SFDA as a cosmetic.

  • SFDA notification
  • Made in Riyadh
  • 50 mL
  • Available through Saudi pharmacies
Investors & partners: see the opportunity
Plazmid Gel tube, black with orange labelling
SFDA · Cosmetic notificationCN-2023-373373Issued 25 September 2023
2019Priority date, Saudi patent application 119410090
6,000+Units sold since SFDA notification
3 settingsIndependent observation settings, two countries
2 channelsSaudi pharmacies and direct export

The gel

One well-studied plant compound. Made to pharmaceutical standards.

No long list of botanicals and no mystery blend. Plazmid is a unique formulation, built around a single defined active, supplied with documented specifications and made in Riyadh.

01

A defined active

Berberine is the bright-yellow alkaloid found in barberry and goldenseal roots. Plazmid uses quality-controlled raw material, not a crude extract.

02

Pharmaceutical manufacturing

Produced by Advanced Pharmaceutical Factory in Riyadh, a licensed facility, under an SFDA cosmetic notification.

03

Registration you can check

Every claim about Plazmid's status is public. Look up the notification number or barcode on the SFDA database yourself.

Product details

Listed name
APF_PLAZMID MASSAGE GEL _FOR SKIN
Formulation
Unique formulation, the subject of Saudi patent application 119410090 (priority March 2019)
Category
Skin products (cosmetic)
Pack size
50 mL tube
SFDA notification
CN-2023-373373
Barcode
6286380001255
Manufacturer
Advanced Pharmaceutical Factory, Riyadh, KSA
Availability
Pharmacies in Saudi Arabia; international orders on request

Using Plazmid Gel

  • Apply a small amount and rub in gently. Follow the directions printed on the pack.
  • For external use on intact skin only.
  • Try a small amount on a patch of skin first.
  • No irritation has been reported to date. If irritation occurs, stop use.
  • Keep out of reach of children.

Where to buy

Find Plazmid Gel

In Saudi Arabia

Ask for Plazmid Gel at your pharmacy. Barcode 6286380001255 helps the pharmacist find it.

Outside Saudi Arabia

Units already ship to customers on several continents. Send an order inquiry and we will reply with availability and delivery.

Send an order inquiry
How do I verify the registration?

Search notification number CN-2023-373373 or barcode 6286380001255 in the SFDA cosmetic products database. The notification was issued on 25 September 2023.

Where can I buy it?

Plazmid Gel is available through pharmacies in Saudi Arabia. Customers outside the Kingdom can send an order inquiry through the contact form; units already ship to customers on several continents.

Have side effects been reported?

No adverse effects, including skin irritation, have been reported to date. If irritation does occur, stop use and speak to a pharmacist or doctor.

The science

Built on the endothelium, not on numbness.

Most topical products in this space work by reducing sensation. The Plazmid research program asks a different question: can a topical compound support the vascular signalling that healthy function depends on?

Research hypothesis · under clinical investigation · not a product claim
BerberinePlant isoquinoline alkaloid, applied topically
eNOSEndothelial nitric-oxide synthase activity supported
Nitric oxideThe key vasodilator signal, often impaired with vascular risk
cGMPSecond messenger; smooth-muscle calcium handling modulated

The target

Nitric-oxide and cGMP signalling, with eNOS at its core, are central to erectile physiology and measurably impaired when diabetes, hypertension or dyslipidaemia are present.

The compound

Berberine has a long record of documented human use and a well-characterised systemic safety profile. Published work shows it improves endothelial function and raises nitric-oxide production.

The route

Topical, site-specific application should limit systemic exposure compared with oral dosing. Topical safety on mucosa is the specific question the trial addresses.

Evidence, stated plainly

What we have seen, and what it does not prove.

We publish the limits of our data alongside the data. That is why the next step is a trial.

Observed

  • Most users reported a longer intravaginal ejaculatory latency time (IELT); some also reported better erections.
  • The pattern held across three independent settings: a consultant urologist in Saudi Arabia, the inventor's practice in Egypt, and unsolicited international testimonials.
  • Reports clustered in men with acquired PE, early ED and vascular risk factors, after one to two months of regular use.
  • No adverse effects reported to date.

Not yet shown

  • No randomisation, no blinding and no control group.
  • Data capture was not pre-specified, and adverse-event reporting was not standardised.
  • The randomized controlled trial is designed to rule out placebo response, expectation and selection bias.
  • These observations generate a hypothesis. They are not evidence of efficacy.
Preprint, 202610.20944/preprints202606.2251.v1 Concept preprint, OSF, 2021 Work of science, copyrightEC-01-002980

Seven years of groundwork

From filing to pharmacy shelf.

  1. Patent application filedSA 119410090
  2. International copyright registeredEC-01-002980
  3. Concept preprint publishedOpen Science Framework
  4. SFDA cosmetic notificationCN-2023-373373
  5. Featured by Egypt's Ministry of Higher EducationMinisterial meeting with the inventor; a roadmap for local production discussed
  6. Updated preprintExpanded observational signal and mechanism

For investors & partners

Commercial today. Clinical validation next.

Plazmid combines an existing manufacturing and distribution base with a defined clinical-development program investigating topical berberine in a potentially underserved sexual-health population.

The trial we are funding

~240patients, stratified by vascular comorbidity
3–4clinical sites in Egypt and the Gulf
12 wkprimary endpoint: IELT
24 morunway to topline data

Randomized, double-blind and placebo-controlled, with regulatory classification confirmed and a therapeutic dossier prepared for the SFDA. Budgeted against published benchmarks for investigator-initiated trials, not guessed.

Live now
Cosmetic sales

Pharmacy distribution in Saudi Arabia plus direct export. The active ingredient is a widely available plant alkaloid, so unit cost stays low as volume grows.

Post-trial
Therapeutic registration

Positive randomized evidence could support the next therapeutic-development and regulatory steps, subject to SFDA requirements.

Either stage
Licensing & partnership

Territory licensing with regional and international pharma partners, and manufacturing pathways identified in Egypt.

Use of funds

A 24-month program to topline data. Round size and terms are in the briefing.

  • Clinical trial50%
  • Regulatory, GMP & IP15%
  • Team & operations12%
  • Data, patient-reported outcomes & statistics8%
  • Contingency15%
Early priority

Filed in March 2019, more than three years before the nearest investigational competitor's published patent.

A real dossier

The SFDA notification rests on a submitted dossier and a defined, specified active ingredient.

Supply in place

Licensed manufacturing and an established distribution channel. A new entrant starts with neither.

Real-world head start

Multi-site user experience since 2019 across two countries. A new entrant starts this clock at zero.

The full investor briefing covers the market, unit economics, use of funds and the raise. It is shared on request with investors, strategic partners and trial co-investors.

Request the briefing

Market

A potentially underserved overlap.

Premature ejaculation affects roughly one in five sexually active men, and acquired PE often coexists with early erectile dysfunction and vascular risk. Guidelines manage each condition, including treatment of concomitant ED, but no marketed option was developed specifically for this overlap. Plazmid is distinguished by its route, its proposed mechanism and its intended research population.

Saudi beachhead: a bottom-up estimate

Built from published figures, using the conservative end of each range. Adjust the two commercial assumptions to test the case.

  1. 16.2MMen aged 20–64 in Saudi Arabia (GASTAT, 2024)
  2. 3.2MWith PE, at ~20% prevalence (global estimate; 27% in one Riyadh clinic sample)
  3. ~970KWith coexisting ED, at 30% (published range 30–76%)
Annual retail value at SAR 150 per unitSAR 5.8M≈ US$1.6M

Assumptions, not forecasts. Retail value is not company revenue. Saudi Arabia only; GCC and export excluded. Sources: GASTAT 2024 via GLMM; J Sex Med 2017 (Riyadh); Transl Androl Urol review; Sex Med 2019.

Global context: treatment markets, US$ billions

Both categories grow at roughly 9% a year; $11.5B combined by 2030.

Current estimate2030
Premature ejaculation treatment
4.62
6.62
Erectile dysfunction drugs
2.92
4.90
0246

Sources: Research and Markets 2026; Grand View Research.

85% ED47% PE

Illustrative only: ED and PE prevalence in one Saudi diabetic cohort, not an estimate of the commercial population. PMC12103089

Competitive landscape
ApproachTargetsDeveloped for the PE + ED overlap?Status
Topical anaestheticsGlans sensitivityNoMarketed
DapoxetineCentral serotoninNoMarketed where licensed
Off-label SSRIsCentral serotoninNoOff-label, systemic effects
PDE5 inhibitorsED onlyPartly: treats concomitant EDMarketed; not a PE therapy
KH-001 (Kadence Bio)Serotonin reuptake + PDE4, oralNoPhase 2a under way (lifelong PE)
Behavioural therapyPsychosexualNoGuideline-endorsed; low uptake
PLAZMIDEndothelial signalling, topical berberineUnder investigationOn sale as a cosmetic; trial next

Founding & clinical team

A pharmacologist, a urologist and a formulator.

MK

Dr. Mina T. Kelleni, MD, PhD

Inventor

Senior Consultant of Pharmacology, Egyptian Medical Syndicate, and Research Fellow at INTI International University, Malaysia. Listed among the Stanford/Elsevier top 2% most-cited scientists, 2022–2025.

MA

Prof. Mohammed J. Alenzi

Clinical lead, Saudi Arabia

Consultant urologist in Saudi Arabia and co-right-holder. Provides the clinical setting for the Saudi observational experience.

ME

Prof. Mohammed H. Elkomy

Formulation

Pharmaceutical scientist and co-right-holder, responsible for developing the Plazmid formulation.

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