Evaluation of salivary thymosin Beta-4 levels, antimicrobial efficacy and pain perception following platelet rich plasma (PRP) administration during orthodontic therapy - Nil

Start Date17 Jul 2025

Sponsor / Collaborator-

CTIS2022-502697-16-00

/ Not yet recruitingPhase 3

SEER-3: A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy - SEER-3

Start Date03 Oct 2023

Sponsor / Collaborator

ReGenTree LLC

NCT05555589

/ RecruitingPhase 3

A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Start Date11 Apr 2023

Sponsor / Collaborator

ReGenTree LLC

100 Clinical Results associated with Thymosin beta-4

100 Translational Medicine associated with Thymosin beta-4

100 Patents (Medical) associated with Thymosin beta-4

268

Literatures (Medical) associated with Thymosin beta-4

03 Apr 2025·Journal of Pharmacy and Pharmacology

Inhaled exogenous thymosin beta 4 suppresses bleomycin-induced pulmonary fibrosis in mice via TGF-β1 signalling pathway

Article

Author: Xu, Junjie ; Yu, Rui ; Liu, Yanhong ; Liu, Zhichao ; Zhang, Qianyi ; Hu, Enbo ; Mao, Yunyun ; Chen, Li ; Li, Xiaohe ; Yang, Cheng ; Zhai, Yanfang ; Li, Shimeng ; Li, Kai ; Zhou, Honggang ; Chai, Dan

AbstractObjectivesIdiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fibrotic interstitial lung disease. The two drugs indicated for IPF have limited efficacy and there is an urgent need to develop new drugs. Thymosin β4 (Tβ4) is a natural endogenous repair factor whose antifibrotic effects have been reported. This study aimed to evaluate the effect of exogenous recombinant human thymosin beta 4 (rhTβ4) on pulmonary fibrosis.MethodsPulmonary fibrosis was induced in mice with bleomycin, and rhTβ4 was administrated by nebulization following three strategies: early dosing, mid-term dosing, and late dosing. The rhTβ4 efficacy was assessed by hydroxyproline, lung function, and lung histopathology. In vitro, the effects of rhTβ4 on fibroblast and lung epithelial cell phenotypes, as well as the TGF-β1 pathway, were evaluated.Key findingsAerosol administration of rhTβ4 could alleviate bleomycin-induced pulmonary fibrosis in mice at different stages of fibrosis. Studies conducted in vitro suggested that rhTβ4 could suppress lung fibroblasts from proliferating, migrating, and activation via regulating the TGF-β1 signalling pathway. In vitro, rhTβ4 also inhibited the epithelial-mesenchymal transition-like process of pulmonary epithelial cells.ConclusionsThis study suggests that nebulized rhTβ4 is a potential treatment for IPF.

01 Feb 2025·Free Radical Biology and Medicine

Enhancing fat graft survival: thymosin beta-4 facilitates mitochondrial transfer from ADSCs via tunneling nanotubes by upregulating the Rac/F-actin pathway

Article

Author: Wang, Qian ; Lin, Yan ; Zhang, Xiaoyu ; Mu, Dali ; Li, Haoran

Autologous fat grafting is a widely used technique in plastic and reconstructive surgery, but its efficacy is often limited by the poor survival rate of transplanted adipose tissue. This study aims to enhance the survival of fat grafts by investigating the role of thymosin beta-4 (Tβ4) in facilitating mitochondrial transfer from adipose-derived stem cells (ADSCs) to adipocytes and newly formed blood vessels within the grafts via tunneling nanotubes (TNTs). We demonstrate that Tβ4 upregulates the Rac/F-actin pathway, leading to an increased formation of TNTs and subsequent transfer of mitochondria from ADSCs. This process mitigates oxidative stress, reduces apoptosis, and promotes revascularization, thereby improving the quality and volume retention of fat grafts. Our findings provide a novel mechanistic insight into the enhancement of fat graft survival and suggest that mitochondrial transplantation and Tβ4 are potential therapeutic strategies to improve clinical outcomes in autologous fat transfer procedures.

01 Nov 2024·Asian Journal of Surgery

Therapeutic potential of thymosin beta 4 in a variety of diseases

Letter

Author: Dai, Qingmei ; Ye, Chaoqun ; Deng, Luyao ; Huang, Huizhi

News (Medical) associated with Thymosin beta-4

24 Aug 2023

·www.pharmaceutical-technology.com

Novaliq pursues EMA approval for dry eye disease drug

Akosua Mireku @AkosuaMireku1 CyclASol is an eye drop solution for dry eye disease. Credit: Andrii Borodai via Getty Images. The European Medicines Agency (EMA) accepted Novaliq’s marketing authorisation application for CyclASol (cyclosporine ophthalmic solution) 0.1% as a treatment for dry eye disease (DED) . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA, using the centralised procedure for all 27 member states of the European Union. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all Companies Intelligence Harrow Health Inc Novaliq GmbH MAA Co Ltd DED Limited C H M P INC View all In order to determine the drug’s approval chances, the CHMP will evaluate results from six clinical trials in CyclASol’s clinical development programme. This includes results from the Phase III ESSENCE-2 trial (NCT04523129) that showed that the eye drops had a good tolerability profile, with a clinically meaningful effect on 71.6% of participants in the cyclosporine group. Germany-headquartered Novaliq received regulatory approval for CyclASol from the US Food and Drug Administration (FDA) as a DED treatment on 30 May. Marketed under the US brand name, Vevye, the drug became the first and only cyclosporine solution approved for the condition with efficacy demonstrated after four weeks of treatment. In the US and Canada, Harrow Health holds the rights to commercialise the DED therapy, as per a July 2023 deal . CyclASol’s mechanism of action works through the binding of cyclosporine to cyclophilin. This complex suppresses a pathological immune response, which prevents ocular inflammation—a major cause of dry eye disease in many patients. The therapy uses Novaliq’s EyeSol technology to avoid the need for water-based excipients. The biotech lists the benefits of this approach as increasing the drug’s bioavailability and providing a longer residual time on the eye amongst other things. Novaliq’s pipeline currently consists of five DED products and seven candidates for other ophthalmologic conditions. The company is also pursuing research for dermatological treatments through a separate entity Dermaliq. The dermatology clinical programme is currently investigating three drug candidates for androgenetic alopecia, psoriasis, and bacterial skin infections, using its proprietary hyliQ drug delivery technology. In a press release , Novaliq’s CEO Christian Roesky said: “The acceptance of the EU marketing authorisation application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. “We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Phase 3Drug ApprovalClinical Result

09 Jun 2023

·www.pharmaceutical-technology.com

Novaliq’s dry eye disease therapy receives US FDA approval

Novaliq’s VEVYE (cyclosporine ophthalmic solution) 0.1% is indicated to treat the signs and symptoms of dry eye disease. Credit: megaflopp via Shutterstock.com. Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease. VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% cyclosporine A in EyeSol, a unique water-free technology that unlocks the potential of cyclosporine A on the ocular surface. The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A. Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks. Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE. The safety and efficacy of VEVYE were assessed in a total of 1,369 patients with dry eye disease, of which 738 received VEVYE. “VEVYE and its novel vehicle were safe, well-tolerated and demonstrated early, consistent and durable therapeutic effects. “It is an exciting moment when you have followed science that finally led into a new category of water-free ocular therapies addressing unmet medical needs for patients suffering from dry eye disease.” In May 2023, the company and Bausch + Lomb received approval from the FDA for MIEBO (perfluorohexyloctane ophthalmic solution) for the same indication.

Clinical ResultDrug Approval

07 Jun 2023

·www.pharmaceutical-technology.com

AstraZeneca ends Phase IV Andexxa trial after positive results

Aidan McNamee An illustration of a blood clot. AstraZeneca’s Andexxa works by acting as a decoy for FXa inhibitors, anticoagulants, that would usually bind to the FXa molecule to produce the anticoagulant effect. Image Credit: KATERYNA KON/SCIENCE PHOTO LIBRARY AstraZeneca has announced it would stop Andexxa’s Phase IV trial after the study achieved its aims earlier than expected. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The ANNEXA-I study (NCT03661528) was designed to assess the use of Andexxa (adexanet alfa) in patients on an oral Factor Xa (FXa) inhibitor treatment including Eliquis (apixaban), which is marketed in the US by Pfizer and Bristol Myers Squibb , and Janssen’s Xarelto (rivaroxaban), who were experiencing an intracranial haemorrhage. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all Andexxa is a modified form of the FXa molecule, an enzyme responsible for blood clotting. The drug works by acting as a decoy for FXa inhibitors, anticoagulants, that would usually bind to the FXa molecule to produce the anticoagulant effect. The treatment had been granted accelerated approval in the US. Under the name Ondexxya, it is also approved in Japan, and conditionally approved in the EU, UK and Switzerland, to treat patients on FXa inhibitors. The study was stopped after a recommendation from the independent Data and Safety Monitoring Board (DSMB) following a planned interim assessment of efficacy. These early results will be a boon for AstraZeneca, which is currently seeking to broaden its cardiovascular, renal and metabolism offerings, believing it to be a key growth driver for the company. Millions of people depend on FXa inhibitors to manage potential blood clots; however, they carry a risk of acute major bleeds, necessitating fast acting reversal agents to maintain patient health. AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Drug ApprovalPhase 2Phase 3Accelerated Approval

100 Deals associated with Thymosin beta-4

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KEGG	Wiki	ATC	Drug Bank
-	Thymosin beta-4	-	DB12003

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Phase 3	United States	HLB Therapeutics Co., Ltd.	-
Neurotrophic keratitis	Phase 3	United States	HLB Therapeutics Co., Ltd.	-
Epidermolysis Bullosa Dystrophica	Preclinical	United States	Lenus Therapeutics LLC	22 May 2019
Epidermolysis Bullosa Dystrophica	Preclinical	United States	Lenus Therapeutics LLC	22 May 2019
Diabetes Mellitus	Preclinical	United States	ReGenTree LLC	01 Dec 2007
Varicose Ulcer	Preclinical	Poland	RegeneRx Biopharmaceuticals, Inc.	01 Jul 2006
Varicose Ulcer	Preclinical	Italy	RegeneRx Biopharmaceuticals, Inc.	01 Jul 2006
Pressure Ulcer	Preclinical	United States	RegeneRx Biopharmaceuticals, Inc.	01 May 2006
Epidermolysis Bullosa	Preclinical	-	RegeneRx Biopharmaceuticals, Inc.	01 Feb 2006
Wounds and Injuries	Preclinical	-	RegeneRx Biopharmaceuticals, Inc.	01 Feb 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02600429 (SEER-1, CTgov)	Phase 3	Neurotrophic keratitis	18	RGN-259 (RGN-259)	pwgwjdbrlp(bsuyhtvyyj) = menghfhrjd govhkjqfsv (vrsoaszfgx, evsenwtpmq - xsezdqjqui) View more	-	14 Aug 2023
				Placebo (Placebo)	pwgwjdbrlp(bsuyhtvyyj) = fjmqyvemcx govhkjqfsv (vrsoaszfgx, hpdqplyhun - jqlbgkuanm) View more
NCT02974907 (ARISE-2, CTgov)	Phase 3	Dry Eye Syndromes	601	RGN-259 (RGN-259)	nzgnjyzrsw(trfgxhfvrb) = atdkiokwof zwqtfufqdu (twaxwrqrtf, swxbnmjwla - dzhmycghwe) View more	-	05 Jan 2022
				Placebo (Placebo)	nzgnjyzrsw(trfgxhfvrb) = gpvclxnlvw zwqtfufqdu (twaxwrqrtf, djcwfcnwje - jjiqpbpdtw) View more
NCT02600429 (SEER-1, AAO2021)	Phase 3	Neurotrophic keratitis First line	18	RGN-259	(abspsxwprb) = hidcbluagb gpzgtzbhoa (hyjwonfden )	Positive	13 Nov 2021
				Placebo	(abspsxwprb) = ycmyelordc gpzgtzbhoa (hyjwonfden )
NCT02600429 (SEER-1, Corporate Publications) Manual	Phase 3	Neurotrophic keratitis	18	RGN-259	idjqirwvbo(rrjjnlhknp) = aifszathaz iqvrenafkh (kiawperbva )	Positive	14 May 2020
				Placebo	idjqirwvbo(rrjjnlhknp) = gxzwodsuwi iqvrenafkh (kiawperbva )
NCT02974907 (ARISE-2, Corporate Publications) Manual	Phase 3	Dry Eye Syndromes	-	Thymosin beta-4	(allhurdmrn) = RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). niceytcnio (chrcpohyzj ) View more	Positive	31 Oct 2017
				Placebo
NCT01387347 (Pubmed) Manual	Phase 2	Dry Eye Syndromes	72	Tβ4	ijjthqlbsz(wshsoxpcrf) = yxmogwqsiq gamzpwnzff (vfbjsafvkp )	Positive	20 May 2015
				Placebo	-
NCT00311766 (CTgov)	Phase 2	Epidermolysis Bullosa \| Wounds and Injuries	30	Thymosin Beta 4+placebo (Placebo)	(bslxvjtyxh) = kmtfhxeplb mpkzleuebq (spzftrsuxo, paotrolink - kaswsfkpjm) View more	-	10 Jun 2013
				Thymosin Beta 4 (Thymosin Beta 4)	(bslxvjtyxh) = bpqwcyrbnh mpkzleuebq (spzftrsuxo, ufodnccxwq - qluzoqanwy) View more
NCT01387347 (CTgov)	Phase 2	Dry Eye Syndromes	72	Thymosin beta 4 (Thymosin Beta 4)	qzxdbfflfq(qedtlgsdcb) = ocbpnmhjcc lklmcksezb (crhawhwzsg, dnvcptbxep - eyeygtbhkq) View more	-	24 Dec 2012
				Placebo (Placebo)	qzxdbfflfq(qedtlgsdcb) = kpztjwanzm lklmcksezb (crhawhwzsg, refuzwlnfp - iglmpobstv) View more

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