A fortifying hair growth active

KOPEXILDiaminopyrimidine

Oxide

Strengthens hair from root to tipPromotes hair thicknessCeases hair lossAccelerates hair growthReinforces hair anchoring

Hair Growth ProcessThe scalp has at an average 100,000 hairs. A healthy scalp sheds hair continuously and new hair replaces them. Hair growth follows a series of cycle.

1. Anagen: Multiplication of group of cells at the base of the hair. Typically lasts from 2 to 6 years.

2. Catagen: The growth in the hair follicles stops and degeneration begins. This phase lasts about 2 to 3 weeks.

3. Telogen: The hair rests and no growth is experienced which lasts 2 to 3 months. Shedding of hair from the follicle.

4. Return to Anagen: The hair follicle re-enters the growth phase. The shed hair is then replaced by a new one.

Normal CycleNormal A:T

• Shrinkage of hair follicles.

• Gradual increase in telogen phase

• Reduction in A:T ratio

Results in hair loss and visible baldness

Any change in Hair growth cycle leads to hair loss, also called as alopecia, is a common problem affecting both men and women.The most common type of hair loss is androgenetic alopecic (AGA) both in men (Male pattern baldness) and women (Female pattern hair loss) and is caused by heredity hormones and genetics.

Hair Loss

Clinically proven to be effective

KOPEXIL Regulatesebalanceseinforces Hair Regrowth

KOPEXIL increases the volume of hair in the growth stage by working on the deep structure of the roots. It rejuvenates the hair roots so that healthy hair growth can persist. The perifollicular fibrosis is a condition in which collagen around the roots becomes rigid, tightens, and pushes the hair out; KOPEXIL helps in softening of the collagen.

History: 2, 4 Diamino-pyrimidine-3-oxide (Aminexil) is a patented chemical molecule developed by L’Oreal and is claimed to help prevent prefollicular fibrosis (scarring of the hair follicles).

KOPEXIL

Trade Name KOPEXIL

INCI Name Diamino Pyrimidine Oxide

Chemical Name 2,4-diamino pyrimidine-3-Oxide

Molecular Formula C4H6N4O

CAS NO 7438-76-9

Harmonized Tariff No. 29335995

Appearance White to off white crystalline powder

Assay by HPLC (on dried basis) 98.0-102.0%

Solubility 1. 1gm Kopexil, soluble in 30 ml water2. 1gm Kopexil, soluble in 10ml of Propylene glycol3. 1gm Kopexil ,soluble in mixture of 25ml water & 5ml Ethanol4. 1gm Kopexil, soluble in mixture of 30 ml Ethanol and 12 ml water.The above solubility observed with sonication at RT.Generally, solubility of Kopexil is poor in all solvents.

Suggested use level 0.2-1.5%

Storage Store in tight sealed container, avoid light and heat

Molecular Structure

Product Specification

Lysyl hydroxylase (LH), an enzyme catalyzes the formation of hydroxylysine, which contributes to the maturation of collagen synthesis. Increased level of collagen causes hardening and shrinking to occur around hair follicles greatly retarding their growth. Over time, the hair follicles die and the scalp becomes visible.

* KOPEXIL is not intended to treat, cure, diagnose or prevent any disease. Kopexil is not a drug. Kopexil is a cosmetic product. This product and its statements have not been evaluated by the FDA.

KOPEXILMechanism of Action

Diaminopyrimidine oxide

KOPEXIL induces a strong reduction in the hair loss, demonstrating its anti-hair loss efficacy.

KOPEXIL induces a visible increase in new hair formation, which clearly indicates stimulation of hair growth process.

Conclusion: Clinical trials of KOPEXIL hair gel shows statistically that, the active ingredient KOPEXIL in hair gel exhibits its anti hair loss property and results in remarkable increase in hair growth, measured by hair counts.

Test Protocol: 35 volunteers between 20-40 years with moderate to severe hair loss. Twice daily application of identically packed KOPEXIL Hair gel for a period of 6 months.

Visual examination & counting of total number of hair in a defined area with magnifying lens

Clinical Efficacyas per available literature

Pattern of increase in new hair after 6 months of treatment

% of people responding % No. of people not responding

Safety Data:• The safety profile of KOPEXIL supports that it is safe to use in Cosmetic Products as per SCCNFP (The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetic and non-food products intended for consumers). At present, the SCCNFP does not recommend any specific warnings or restrictions under the currently proposed conditions of use.

• Evaluation of acute toxicity (oral, dermal), skin and mucous membrane irritation, sensitization, sub-chronic toxicity (oral, dermal), chronic (oral, dermal), reproductive toxicity (oral), genotoxicity, carcinogenicity, percutaneous absorption have shown that the compound can be safely used.

Regulatory Status*:Not approved by FDAEurope : Allowed for personal care applicationUSA : Allowed for personal care applicationJapan : Allowed in selected product categoryRest of world : Allowed for use in most of the Asian countries

*Consult your regulatory authority for use level and restrictions.

Safety Data & Regulatory Status

Features Benefits

Preventing the stiffening of follicles & Inhibits LH enzyme.

Activation of hair follicles and No miniaturization of follicles

Eliminates the perifollicular fibrosis condition reducing inflammation

Increases blood flow to the root and Strengthens hair anchoring with maximum efficacy

Enhances the anagen phase of hair Reverses the hair loss process and helps hair regrowth

It enhances m RNA synthesis in the matrix cells

Increases hair volume. Faster visible result with less concentration

KOPEXIL

Recommended dosage:Recommended dosage of Kopexil which can be used safely in cosmetic products at concentrations up to 1.5 %

Applications:-Hair Serum -Hair Conditioner-Hair Lotion -Hair Gel-Hair Shampoo -Hair Cream

Recommended Dosage &Applications

Reference FormulationsIngredients In %

ACarbopol 0.70

Disodium EDTA 0.05

Methyl paraben 0.20

Water qs to 100B Kopexil 1.00

D-Panthenol 0.20

Glycerin 2.00

Ethanol qsC

Colour qs

Perfume qs

D Triethanolamine 2.00E

PVP 0.50

Tween 20 qs

Hair Gel with Kopexil

Reference Formulations

Hair Cream with Kopexil

S.NO. INGREDIENTS QUANTITY IN %

01 CARBOPOL 0.400

02 EDTA 0.050

03 STEARIC ACID 6.000

04 CETYL ALCOHOL 2.000

05 LIGHT LIQUID PARAFIN 10.000

06 ETHYLENE GLYCOL DISTERATE 2.000

07 LANOLIN 0.200

08 POTASSIUM HYDROXIDE 0.500

09 TRIEHANOL AMINE 0.200

10 SODIUM LACTATE 0.100

11 GLYCERINE 1.000

12 POLYQUARTZ-7 0.200

13 KOPEXIL 1.000

14 D-PANTHENOL 0.100

15 PERFUME 0.400

16 WATER qs

Reference Formulations

Hair Shampoo with Kopexil

Ingredients In %

A Kopexil 1.00

D-Panthenol 0.20

Disodium EDTA 0.10

Methyl paraben 0.20

Propyl paraben 0.10

Distilled water qs to 100

B Sodium lauryl sulphate 5.00

Sodium laureth sulphate 35.00

Dow corning conditioning agent 0.50

C Colour qs

Perfume qs

D Coco diethanolamide 2.00

Cocamido propyl betaine 8.00

04/09/2023 HGKP/MKTG/001 14

Company: DS LaboratoriesBrand Name: Spectral DNCLocation: USA

Company: GlenmarkBrand Name: Hair4ULocation: INDIA

Company: L’orealBrand Name: Vichy DercosLocation: Paris

Kopexil Brands in the Market

04/09/2023 HGKP/MKTG/001 15

Company: MaricoBrand Name: Hair Gain TonicLocation: India

Company: UAS PharmaBrand Name: NeutridermLocation: Australia

Company: Perox FarmaBrand Name: MussvitalLocation: Spain

Kopexil Brands in the Market

References:• Gerhard J. Nohynek et. al. Safety assessment of personal care products/cosmetics and their ingredients. Elsevier Toxicology and Applied Pharmacology 243 (2010) 239–259.• Mahé YF; Buan B; Bernard BA. A minoxidil-related compound (Aminexil) lacking a C6 substitution still exhibits strong anti-lysyl hydroxylase activity in vitro. Skin Pharmacol, 9(3):177-83 1996• TA Wynn. Cellular and molecular mechanisms of fibrosis. The Journal of Pathology 2 214(2008) 199–210.

Disclaimer: The information given and the recommendations made herein are based on literature search and are believed to be accurate but no guarantee of their accuracy is made. Information is supplied upon the condition that the receivers will make their own determination as to its suitability for their purposes prior to use. In no event will KUMAR ORGANIC PRODUCTS LTD be responsible for the damage of any nature whatsoever resulting from the use of or upon reliance of the information

THANK YOU

KOPEXIL