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Aminexil


Aminexil (diaminopyrimidine oxide)

2-4 Diamino Pyrimidine-3-Oxide) is a similar compound to Minoxidil that prevents premature aging or rigidification of collagen, but without the possible side effects (scalp irritation, redness, itching).

Is it safe?  Are there side effects?

There are none directly associated with this topical solution. At present, the SCCNFP does not recommend any specific warnings or restrictions under the currently proposed conditions of use 

EFFECTS ON HAIR LOSS

Through the softening and improvement of elasticity to this collagen structure, micro capillary blood flow to the follicle is enhanced allowing stronger and more vigorous hair growth, particularly in follicles that are becoming compromised. Clinical Trials have demonstrated that Diamino Pyrimidine Oxide) preserves and strengthens hair fibres. In a Trial involving over 100 men it was shown to slow hair loss after 3 weeks and maintain an additional 8% of hair in the growth (anagen) phase after 6 weeks. A solution containing 1.5% 2,4-DPO in ethanol/water at least three times a week.

STRUCTURE & SYNTHESIS

Originally developed by a French company named Vichy.

MECHANISMS OF ACTION

Inhibits Lysyl Hydroxylase, an enzyme participating in the maturation and hardening of the collagen structure of the hair follicle.

Dosage Level 0.2%-1.5% Clinical efficacy of KOPEXIL hair gel manufactured by Kumar Organic Products Pvt Ltd in stimulating hair growth N NNH2 NH2 O Pattern of increase in new hair after 6 months of treatment Corporate Office: KUMAR ORGANIC PRODUCTS LTD NO# 819/C, 13th cross, 7th block (West), Jayanagar, Bangalore-560082, Karnataka, India.

  1. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I KUMAR ORGANICS WELCOMES FOR PRESENTATION ON 1 Presented By Dr Ramkrishna Gupta Global Technical Head Kopexil Aqua-A clinically proven 100 % water soluble Hair growth stimulant Clinical study No.: ICB1101KOP02IP02P2
  2. Orasan MS, Bolfa P, Coneac A, Muresan A, Mihu C. Topical Products for Human Hair Regeneration: A Comparative Study on an Animal Model. Annals of Dermatology. 2016;28(1):65-73. doi:10.5021/ad.2016.28.1.65.
  3. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Why Hair is Important 2 Kareena Kapoor-Top Bollywood actress Although Hair is dead tissue, but play a very important role to enhance the beauty
  4. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Hair Science • Hair is made of a structural protein called keratin. • Two major parts: A) Hair Shaft B) Hair follicle or hair bulb. • At the base of the follicle is the dermal papilla, feed by the bloodstream which carries nourishment to produce new hairs. 3
  5. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I • Any change in Hair growth cycle leads to hair loss, is a common problem affecting both men and women. • Hair loss is a multi-factor disorder, happened due to below given reasons. • Shrinkage of hair follicles. • Gradual increase in telogen phase • Reduction in A:T ratioResults in hair loss and visible baldness Hair Loss 4
  6. 5. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 5 Market Potential of Hair Care products •Global Hair Care Products Industry Revenue is Forecast to Reach an Estimated $82.2 Billion in 2018 . • The global hair care products industry mainly comprises the manufacturers of all hair care products such as shampoos, conditioners, hair oils, hair colorants, hair treatment products, and hair styling products. • Europe dominated this industry with the highest market share of approximately 43%, followed by Asia Pacific. • Asia Pacific has emerged as the fastest-growing region in the industry.
  7. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I FDA approved hair growth stimulants 6 • Minoxidil and Finasteride are only FDA approved molecules for Hair growth, comes under schedule H and cannot be used for cosmetic applications. • Minoxidil is treated as a gold standard but it is insoluble in water and containing high concentrations of alcohol which makes scalp dry and resulting in dandruff. • Minoxidil also affects on blood pressure, so not ideal for BP patients. • Kumar organic R&D team developed the innovative hair growth molecule which is 100 % soluble in water and having strong anti-oxidant property.
  8. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Do you want to be free from dandruff, itchy scalp, irritation due to alcohol based hair growth stimulant products??? Then try Kopexil Aqua 7 Kopexil Aqua
  9. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Solutions Hair loss 8 4Hair Loss prevention Men & Women AQUAPRODUCTS PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”
  10. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Efficacy Studies 9 PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH” • In-Vitro Assay (DHT release assay) • SHH gene expression (m-RNA expression) • Clinical study
  11. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I DHT Release assay • In-Vitro study was conducted in DU-145 (human prostate cancer) cells because having DHT-R 10 Kopexil Aqua is potent molecule to reverse the effect of Testosterone on DHT release
  12. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Effect of Kopexil Aqua on SHH gene activation 11 Up-regulation of 12.6% increase of SHH gene expression again proof that Kopexil aqua is a potent hair growth molecule. SHH mRNA level % Improvement after month 4 FD/WBF/KX-38 12.6% • Sonic Hedgehog gene (SHH) is activated through WNT activation and leads to hair growth • SHH gene expression was measured through RT-PCR
  13. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Clinical Study 12
  14. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Clinical Efficacy evaluation of Kopexil Aqua- A POP study •A- Minoxidil 5 % •B. Kopexil Aqua 3 % (active content 1.5 %) 13 Objective of the study: To evaluate the safety and efficacy of Kopexil Aqua hair growth stimulants through open label, randomized study for the treatment of mild to moderate Androgenic Alopecia in Male human volunteers Test Hair growth stimulants:
  15. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Study design • Allocation: Randomized • Clinical Parameters: Efficacy Study/Safety • Duration of study: 5 months • Gender: Male • Route of application: Topical • Doses: 1 ml/ application (twice in a day) • No. of volunteers/ group: 12 14
  16. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Primary Endpoints: • Hair density • Anagen/ telogen ratio (A/T ratio) • Hair diameter • Hair growth rate • Global photography assessment (Grade change) • m-RNA expression (SHH gene) Secondary endpoints: • Dermal tolerability • Consumer perception assessment 15 Clinical Parameters All the continuous variables were analyzed by using the Analysis Of Variance (ANOVA) test using SAS 9.2. Then the pair wise comparison of the treatment groups were done by using the post hoc methods i.e. Bonferroni’s or Fisher’s LSD.
  17. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Effect of Kopexil Aqua on Hair Density 16 *indicates that p value is <0.05 when compared from baseline % improvement at month 2, month 4 and month 5 0 2 4 6 8 10 12 14 Baseline Month-5 MeanScore Effect of Kopexil Aqua on Hair Density 69 % Kopexil Aqua increases the hair density by 69 % at month 5 Baseline Fifth Month
  18. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Anagen telogen ratio (A/T ratio) 17 *indicates that p value is <0.05 when compared from baseline % improvement at month 2, month 4 and month 5 0 2 4 6 8 10 Baseline Month-5 MeanScore Effect of Kopexil Aqua on Anagen/Telogen Ratio 29 % Kopexil Aqua activates the Anagen phase of hair cycle and increases the A/T ratio by 29 % at 5th month Telogen Anagen
  19. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I HAIR DIAMETER 18 63 64 65 66 67 68 69 70 71 72 Baseline Month-5 66.25 72 HairDiameterinuM Effect of Kopexil Aqua Hair Diameter 8.6 % Kopexil Aqua increases the hair diameter by 9 % at month 5, hence helps to increase the hair volume
  20. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Consumer Perceptions for Kopexil Aqua’s efficacy 19 Question Responses Month 1 Month 2 Month 5 Bald spot getting smaller Agree 0% 22% 50% NA/DA 87.5% 67% 50% Disagree 12.5% 11% 0% Appearance of hair Better 25% 56% 50% No change 37.5% 33% 50% Best 37.5% 11% 0% Growth of hair Increased 50% 89% 50% Decreased 0% 0% 0% No change 50% 11% 50% Effect of treatment Effective 62.5% 89% 100% Very effective 0% 0% 0% Not effective 37.5% 11% 0% Satisfaction with appearance on area Front 75% 45% 50% Top 25% 33% 0% Overall 0% 22% 50% More than 50 % volunteers observed the significant improvement for all the parameters
  21. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 20 Product’s Name Hair density (%) Hair diameter Hair growth rate Anagen/Teloge n ratio SHH m-RNA expression (%) Grade Change Safety Minoxidil 5% 53.8 56±0 66% 50% 6.3 100 No adverse effects observed (KOPEXIL AQUA 3 %) 69 72 100 45.9 12.6 100 No adverse effects observed Over all Efficacy Kopexil Aqua> Minoxidil Efficacy Comparison Chart of Minoxidil Vs Kopexil Aqua(Baselines Vs 5th months) The Kopexil Aqua is more effective than Minoxidil for the treatment of mild to moderate Androgenic Alopecia in Male Patients
  22. Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Major benefits/Claims of Kopexil Aqua 21 Kopexil Aqua 100 % Water soluble, No dry scalp, dandruff, itchy-ness Activates the active phase of hair Accelerates hair growth Potent 5α reductase inhibitor Increases Hair density Strong anti- oxidant PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH” Active registered in Pre REACH registration