This document discusses Kopexil, an active ingredient that promotes hair growth in 3 ways: 1) It regulates and rebalances the hair growth cycle by inhibiting the enzyme lysyl hydroxylase and preventing stiffening of hair follicles. 2) It reinforces hair anchoring and increases blood flow to hair roots by eliminating perifollicular fibrosis. 3) It enhances the growth (anagen) phase of the hair cycle and increases hair volume, helping to reverse hair loss and stimulate new hair growth.

1. Strengthens hair from root to tip
Promotes hair thickness
Ceases hair loss
Accelerates hair growth
Reinforces hair anchoring

2. Hair Growth Process
The 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.
Normal Cycle
Normal A:T 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.

3. Hair Loss
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.
• Shrinkage of hair follicles.
• Gradual increase in telogen phase
• Reduction in A:T ratio
Results in hair loss
and visible baldness

4. KOPEXIL
R
egulates
ebalances
KOPEXIL einforces Hair Regrowth
Clinically proven to be effective
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).

5. Product Specification
Trade Name KOPEXIL
INCI Name Diamino Pyrimidine Oxide
Chemical Name
2,4-diamino pyrimidine-3-Oxide
Molecular Formula C4H6N4O
Molecular Structure
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 water
2. 1gm Kopexil, soluble in 10ml of Propylene glycol
3. 1gm Kopexil ,soluble in mixture of 25ml water & 5ml Ethanol
4. 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

6. KOPEXIL
Mechanism of Action
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.
Diaminopyrimidine oxide
* 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.

7. Clinical Efficacy
as per available literature
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
Pattern of increase in new hair after 6 months of treatment
% of people responding % No. of people not responding
KOPEXIL induces a strong KOPEXIL induces a visible increase in
reduction in the hair loss, new hair formation, which clearly
demonstrating its anti-hair indicates stimulation of hair growth
loss efficacy. 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.

8. Safety Data &
Regulatory Status
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 FDA
Europe : Allowed for personal care application
USA : Allowed for personal care application
Japan : Allowed in selected product category
Rest of world : Allowed for use in most of the Asian countries
*Consult your regulatory authority for use level and restrictions.

9. KOPEXIL
Features Benefits
Preventing the stiffening of follicles Activation of hair follicles and No
& Inhibits LH enzyme. miniaturization of follicles
Eliminates the perifollicular fibrosis Increases blood flow to the root and
condition reducing inflammation 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 Increases hair volume. Faster visible
matrix cells result with less concentration

10. Recommended Dosage &
Applications
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

11. Reference Formulations
Ingredients In %
A
Carbopol 0.70
Disodium EDTA 0.05
Methyl paraben 0.20
Water qs to 100
B
Kopexil 1.00
D-Panthenol 0.20
Glycerin 2.00
Ethanol qs
C
Colour qs
Perfume qs
D Triethanolamine 2.00
E
PVP 0.50
Tween 20 qs

12. Reference Formulations
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

13. Reference Formulations
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

14. Kopexil Brands in the Market
Company: DS Laboratories Company: Glenmark Company: L’oreal
Brand Name: Spectral DNC Brand Name: Hair4U Brand Name: Vichy Dercos
Location: USA Location: INDIA Location: Paris
2/10/2013 HGKP/MKTG/001 14

15. Kopexil Brands in the Market
Company: Marico Company: UAS Pharma Company: Perox Farma
Brand Name: Hair Gain Brand Name: Neutriderm Brand Name: Mussvital
Tonic Location: Australia Location: Spain
Location: India
2/10/2013 HGKP/MKTG/001 15

16. 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