Characterization of Night Vision Impairment in Choroideremia and Short-Term Vitamin A Supplementation: The Dark-Adapted Retinal Function Response in Choroideremia (DARC) Study

Choroideremia (CHM) is an inherited retinal disorder that causes progressive vision loss, ultimately leading to complete blindness. The first symptom is generally night blindness, although, to date, little is known about the extent, type, pattern, and progression of dark-adapted visual function measures in CHM patients. We hypothesize that one of the key events causing night blindness in CHM is deficiency in the chromophore of the rod visual pigment, rhodopsin. We propose that this deficiency is at least in part due to inadequate delivery of vitamin A (all-trans-retinol) to the photoreceptors (PRs) from the ailing retinal pigment epithelium (RPE), characteristic of CHM. We hypothesize that increased availability of vitamin A would potentiate its entry into the RPE-mediated visual cycle, ultimately enabling delivery to the PRs. This would in turn allow rods to perform better by partially overcoming the RPE damage and the impaired chromophore recycling that we postulate exists in CHM. The goals of this proposal are: (1) to test the hypothesis that oral vitamin A supplementation can improve night time and peripheral vision in CHM patients, and (2) to provide detailed characterization of dark-adapted visual function outcome measures to guide interventional CHM trials.

Start Date01 May 2023

Sponsor / Collaborator

Duke University

[+1]

JPRN-jRCTs031200260

/ CompletedNot ApplicableIIT

Evaluation of a cosmetic gel containing retinol palmitate for its improvement effect on wrinkles

Start Date07 Jan 2021

Sponsor / Collaborator-

JPRN-UMIN000042403

/ CompletedNot ApplicableIIT

Evaluation of neck wrinkle improvement by liquid containing retinol palmitate :a randomized, double blind, placebo-controlled study - Evaluation of neck wrinkle improvement by liquid containing retinol palmitate

Start Date17 Nov 2020

Sponsor / Collaborator-

100 Clinical Results associated with Vitamin A Palmitate

100 Translational Medicine associated with Vitamin A Palmitate

100 Patents (Medical) associated with Vitamin A Palmitate

2,961

Literatures (Medical) associated with Vitamin A Palmitate

01 Jul 2025·Analytical and Bioanalytical Chemistry

Proposed RP–HPTLC–FLD kit for analysis of vitamin A palmitate in edible oils

Article

Author: Meyer, Daniel ; Hörnlein, Sophia ; Rein, Dietrich ; Morlock, Gertrud E

Abstract:

Preschool-aged children and non-pregnant women of reproductive age particularly in countries of a lower socio-demographic index may experience insufficient dietary vitamin A. Fortifying staple foods such as edible oils with vitamin A is a useful approach to reduce malnutrition. To enable better quality oil fortification, producers need reliable and inexpensive tools for assessment of the vitamin A contents of their products. A simple reversed-phase high-performance thin-layer chromatography fluorescence detection (RP–HPTLC–FLD) method was developed and studied for the quantification of vitamin A palmitate (VAP) in five edible plant oils. The challenging matrices of non-refined palm kernel oil and soybean oil, which are known to interfere with the accuracy of some easy-to-use test kits, were separated from VAP using the new RP–HPTLC–FLD method. The standard addition method provided good accuracy and acceptable calibration curves (coefficients of determination R2 between 0.9874 and 0.9999) even for manual application. The developed RP–HPTLC–FLD method proved simple, robust, sustainable, cost-efficient, and suitable for low-tech (minimum equipment) on-site analysis. Graphical Abstract

01 Jun 2025·ANIMAL FEED SCIENCE AND TECHNOLOGY

Evaluating the inclusion of Clostridium autoethanogenum protein instead of fishmeal protein in diets for European seabass (Dicentrarchus labrax): Growth performance, digestive enzymes, health status, and tissues investigations

Author: Abdelhakim, Taghrid M. N. ; Saad, Adel H. ; Abd El-Ghaffar, Haytham A. ; Abdel-Tawwab, Mohsen ; Abo Selema, Talal A. M. ; Abdelsalam, Mohamed ; Khalil, Riad H. ; Sabry, Eman A.

The Clostridium autoethanogenum-derived protein (CAP) is a microbial protein generated during ethanol fermentation of agricultural byproducts.The present investigation evaluated the use of CAP as a sustainable alternative to reduce fishmeal (FM) dependency in aqua-feeds.A 70-day feeding trial was done to examine the impacts of partially replacing FM protein by CAP at 0% (control, CAP0), 10% (CAP10), 20% (CAP20), 30% (CAP30), and 50% (CAP50) inclusion levels in diets for European seabass (Dicentrarchus labrax) juvenile (initial weight 10.5 ± 1.5 g).Results obtained demonstrated that dietary CAP incorporation up to 50% FM replacement did not significantly (P< 0.05) impact the growth performance, feed efficiency, or survival rates.Similarly, the expression levels of growth-related genes (IGF-1 and GH) remained unchanged across treatments.The intestinal digestive enzymes activities, including lipase, alpha-amylase, and proteases, as well as the haematol. parameters remained unaffected by the dietary CAP inclusion levels.Histol. assessment revealed normal tissue architecture in the intestine, liver, and spleen of fish fed on CAP-containing diets.That indicats no adverse effects of CAP on organs′ structure.A simple economic anal. showed reduced feed costs with increasing CAP inclusion, where production costs per ton of fish gain decreases by 19.3% at 50% FM replacement compared to the control diet.These findings establish that CAP is a viable and cost-effective protein source capable of replacing up to 50% FM protein in practical diets for D. labrax juveniles without compromising their growth, health status, or organs′ structure.

16 May 2025·ACS food science & technology

Study on Photodegradation Mechanism and Kinetics of Vitamin A and Derivatives under Ultraviolet Irradiation

Author: Yin, Hong ; Zhang, Qilei ; Chen, Zhirong ; Zhang, Shuyu ; Yuan, Shenfeng

Vitamin A and its derivatives, including retinol (RE), retinyl acetate (RA), and retinyl palmitate (RP), are widely used in the food industry.However, their poor photostability limits their applications.This study investigated the photodegradation of RE, RA, and RP under UV irradiation and proposed two strategies to enhance their stability.All three compounds underwent isomerization to the 9-cis forms.RE degraded mainly via a free radical chain reaction, whereas RA and RP predominantly followed an ionic photodissociation mechanism to form anhydroretinol (AR).The addition of butylated hydroxy toluene (BHT) improved RE stability, increasing its retention by 12.49% after 4 h.Using iso-Pr alc. as the solvent inhibited AR formation from RA and RP, thereby increasing their retention by 17.12% and 16.26%, resp., compared to ethanol.These findings provide a basis for selecting vitamin A and its derivatives and improving their UV stability in food systems.

News (Medical) associated with Vitamin A Palmitate

13 May 2025

·www.prnewswire.com

Particles for Humanity Celebrates Codex Adoption of Key Ingredient in PFH-VAP for Use in Sugar and Rice

CAMBRIDGE, Mass., May 13, 2025 /PRNewswire/ -- Codex Alimentarius Commission ("Codex") has expanded its list of foods in which basic methacrylate copolymer (BMC) can be used as a food additive. BMC is a key ingredient in Particles for Humanity's lead product, PFH-VAP. Codex is an international organization that sets food safety and quality standards, including the General Standard for Food Additives (GSFA). PFH-VAP is a more stable formulation of vitamin A palmitate being developed for use in large scale food fortification to address vitamin A deficiency, which affects about 190 million preschool-age children, mostly from Africa and South-East Asia. BMC is the unique encapsulation material in PFH-VAP that increases vitamin A stability by protecting the micronutrient from moisture and oxygen. BMC has decades of safe use in humans and has been approved for use in food supplements in Europe since 2010. BMC being adopted as a food additive for a specific GSFA food category is a critical safety signal to food manufacturers and national regulators. BMC was previously adopted by Codex in multiple food categories, like salt, flours, and soups and broths, including bouillon, which is widely consumed in West Africa. The expanded list of food vehicles now includes sugar and rice, which would help broaden PFH-VAP's impact in Africa and Asia. President of the National Codex Alimentarius Committee in Senegal, Professor Amadou Diouf, shared, "This use of BMC is an excellent innovation. It represents a major opportunity to solve deficiencies, particularly those related to sensitive micronutrients such as Vitamin A, essential in the fight against micronutrient deficiency to which our populations are exposed." A team from Codex Senegal sponsored the proposal to Codex, navigating the two-year, eight-step Codex adoption process to expand BMC's listing on the GSFA. Codex was established by the Food and Agriculture Organization and the World Health Organization and comprises 188 member countries, which make decisions by consensus. Regulators in countries around the world reference Codex for guidance on safe use of food additives. Once an additive has been adopted by Codex for a food category, it can generally be considered safe for use in that food per the guidance. Expanding the number of GSFA food categories in which BMC can be used eases acceptance of BMC by regulatory bodies worldwide. It supports the potential for PFH-VAP to be used in foods, like sugar and wheat flour, where many governments around the world require vitamin A fortification. Fortifying more foods with PFH-VAP will help combat vitamin A deficiency, a devastating public health problem in many low-income countries. Particles for Humanity transforms early-stage medical technology into products for people living in low and lower-middle income countries, with 100% of funding from philanthropy. Its rigorous product development process is based on end-user input and is focused on financially sustainable product opportunities. Visit or contact [email protected] SOURCE Particles for Humanity WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

24 Jul 2023

·www.globenewswire.com

Advent Therapeutics Receives FDA Rare Pediatric Disease Designation for Retinol Palmitate for Prevention of Bronchopulmonary Dysplasia in Premature Infants

Reinventing Vitamin A for neonatal and pediatric unmet medical needs Bronchopulmonary Dysplasia (BPD) is most frequent serious complication of preterm birth – US preterm births highest in 15 years Advent plans FDA PDUFA Meeting late-2023 to establish pathway for US approval of lead injectable product Advent Therapeutics, Inc., a late-stage biotechnology company developing precisely optimized retinol palmitate (vitamin A) drug products as both injectable and breakthrough non-invasive inhaled neonatal lung therapies, announced today that it has received U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Designation (RPDD) for its vitamin A metabolic and reparative respiratory drugs for the prevention of Bronchopulmonary Dysplasia (BPD) in premature infants. FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases. Companies that receive approval for a New Drug Application (NDA) for a rare pediatric disease may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product or sold to another sponsor for priority review of their marketing application. This program is intended to encourage the development of new drugs and biologics for the treatment of rare pediatric diseases. “We are acutely focused on BPD as an area of high unmet medical need that presently has no FDA-approved therapies for prevention or treatment. The FDA Rare Pediatric Disease Designation is an important addition to the Orphan Drug designations previously granted by the US FDA and the European EMA for our vitamin A metabolic and reparative respiratory drugs,” said Dave L. Lopez, CEO of Advent Therapeutics. ABOUT BPD BPD is a rare disease and the most common serious complication facing premature infants, resulting in significant morbidity and mortality. It is an extremely costly respiratory disorder afflicting premature infants for which there is currently no approved drugs worldwide. Annually, in both US and Europe, there are approximately 100,000 premature infants at-risk for BPD and many more in Asia-Pacific, Latin America and throughout the world. In the US, hospital costs for treating a BPD infant in the first year average $442,000 with an average hospital stay of 103 days. US healthcare costs of treating babies with BPD have been estimated as approaching $2.5 billion per year. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugNDAPriority Review

100 Deals associated with Vitamin A Palmitate

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-	Vitamin A Palmitate	D10AD02 R01AX02 S01XA02	-

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Approved

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Indication	Country/Location	Organization	Date
Xerophthalmia	China	-	08 Mar 1999
Keratomalacia	Japan	Sannova KK	30 Sep 1977
Night Blindness	Japan	Sannova KK	30 Sep 1977
Vitamin a Deficiency	United States	Casper Pharma LLC	18 May 1949

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchopulmonary Dysplasia	Preclinical	United States	Advent Therapeutics, Inc.	20 Jul 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03478878 (CTgov)	Early Phase 1	Age Related Macular Degeneration \| Reticular Dystrophy of Retinal Pigment Epithelium	9	IP+Vitamin A palmitate (Cohort 1)	magngbrmcy(dclnvvkrnj) = zmonzldyqq moagpotxhx (adwepkxlmf, 11.894) View more	-	03 Jul 2024
				IP+Vitamin A palmitate (Cohort 2)	magngbrmcy(dclnvvkrnj) = qzypdrelaw moagpotxhx (adwepkxlmf, 16.405) View more
NCT03478865 (CTgov)	Early Phase 1	Age Related Macular Degeneration \| Glycogen Storage Disease Type II	8	IP+Vitamin A palmitate (Cohort 1)	uvwogtadhl(mhxeovhrip) = vdodobxcdp vhdejjhyfy (rtplncgwdw, 10.755) View more	-	31 May 2024
				IP+Vitamin A palmitate (Cohort 2)	uvwogtadhl(mhxeovhrip) = ilhzjeoisx vhdejjhyfy (rtplncgwdw, 6.793) View more

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