This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

Start Date01 Jun 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

NCT06450405 / Not yet recruitingNot ApplicableIIT

Androgen Effects on the Reproductive Neuroendocrine Axis

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Start Date01 Jun 2024

Sponsor / Collaborator

University of California San Diego

[+2]

NCT06039371 / RecruitingPhase 2IIT

SPECTRA: SupraPhysiological Androgen to Enhance Chemotherapy TReatment Activity

This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide together may be an effective treatment for metastatic castration-resistant prostate cancer.

Start Date21 May 2024

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Testosterone Cypionate

100 Translational Medicine associated with Testosterone Cypionate

100 Patents (Medical) associated with Testosterone Cypionate

488

Literatures (Medical) associated with Testosterone Cypionate

01 Feb 2024·Life sciences

Prolonged testosterone 17β-cyclopentylpropionate exposition induces behavioral, ovarian, oviductal, uterine and reproductive disturbances in female mice

Article

Author: Gonçalves, Reggiani V ; Castro-Gamero, Angel Mauricio ; Santos, Eliziária C ; Gonçalves-Santos, Elda ; Novaes, Rômulo D ; Barcelos, Mônica N ; Souza, Matheus A

Anabolic-androgenic steroids (AAS) abuse is often associated with metabolic disorders and infertility. However, the current evidence on AAS-induced reproductive toxicity is mainly based on male studies. Thus, AAS repercussions on female reproductive capacity remain poorly understood, despite scarce evidence that fertility determinants may be more severely impaired in females than males exposed to these drugs. Accordingly, this study used an integrated framework to investigate the impact of different testosterone 17β-cyclopentylpropionate (TC) doses on pain sensitivity, aggressiveness, anxiety, sexual behavior, ovarian, oviductal, uterine and reproductive morphofunctional and molecular outcomes. These parameters were used to explore the reproductive capacity in female mice exposed to this synthetic testosterone ester. The animals were untreated or intraperitoneally treated with 5, 10 and 20 mg/kg TC every 48 h for 12 weeks. Our findings indicated that testosterone was upregulated while the hormones luteinizing, follicle-stimulating, estrogen and progesterone were down-regulated by TC. This AAS also exerted deleterious effects on anxiety, aggressivity, nociception, exploratory and sexual behavior in female mice. Concurrently, TC attenuated ovarian follicle maturation, interrupted the estrous cycle, induced oviductal and uterine hypotrophy. Estrous cyclicity was reestablished 60 days after AAS treatment. However, TC-treated mice still exhibited impaired reproductive capacity, a disturbance potentially related to deficiency in folliculogenesis, sex hormones production, and endometrial receptivity mediate by ER-α, PR, HOXA-10 and LIF down-regulation. Taken together, our findings indicated that in addition to female behavior, reproductive organs microstructure and function are markedly impaired by TC in a dose-dependent manner, whose time-dependent reversibility remains to be clarified.

29 Jan 2024·Journal of pediatric endocrinology & metabolism : JPEM

Hypothalamic-pituitary dysfunction in Sturge–Weber syndrome: case report and review of the literature

Review

Author: Baer, Tamar ; Brutsaert, Erika ; Hadid, Somar A ; Jacobson, Ronald I ; Noor, Laila

Abstract:

Objectives:

Sturge–Weber syndrome (SWS) is a rare neurocutaneous disorder that is characterized by a segmental dermatomal facial port-wine stain birthmark and is frequently accompanied by ipsilateral brain and eye abnormalities. We present a case of a patient with SWS who exhibited hypogonadotropic hypogonadism, growth hormone (GH) deficiency, and central hypothyroidism at the age of 20 despite the absence of radiographic findings in the pituitary and hypothalamus.

Case presentation:

A 20-year-old male with SWS with epilepsy and Klippel–Trenaunay syndrome presents with delayed pubertal development, short stature, and obesity. Upon further examination, he was found to have biochemical and clinical evidence of hypogonadism, hypothyroidism, and GH deficiency. A pituitary MRI displayed no abnormalities of the pituitary or hypothalamus. Treatment with testosterone cypionate and levothyroxine was initiated. Despite successful pubertal induction, IGF-1 levels have remained low and treatment with recombinant human growth hormone (rhGH) is now being considered for metabolic benefits.

Conclusions:

This case emphasizes the importance of endocrine evaluation and treatment of hormonal deficiencies in patients with SWS despite the absence of radiographic findings.

23 Sep 2023·Endocrinology

Puberty Suppression Followed by Testosterone Therapy Does Not Impair Reproductive Potential in Female Mice.

Article

Author: Uliasz, Tracy F ; Godiwala, Prachi ; Lowther, Katie M ; Mehlmann, Lisa M ; Kaback, Deborah

More adolescents are coming out as transgender each year and are put on puberty blockers to suppress natal puberty, which is then followed by cross-hormone treatment to achieve puberty of the desired gender. Studies to examine the effects of puberty suppression and virilizing therapy on future reproductive potential among transgender males are lacking. This study used a translational murine in vitro fertilization model to examine the effects of female puberty suppression with depot leuprolide acetate (LA), followed by virilizing therapy with testosterone cypionate (T), on embryologic and pregnancy outcomes. LA effectively inhibited puberty when mice were treated beginning at 3 weeks of age. LA treatment was associated with higher mouse weight but lower ovarian weight. LA-treated mice ovulated developmentally competent eggs in response to gonadotropin administration, albeit at a higher dose than controls. Ovaries from mice treated with LA and T produced oocytes that had morphologically normal meiotic spindles after in vitro maturation and responded to gonadotropin stimulation. Eggs from mice treated with LA and T were fertilizable and produced developmentally competent embryos that led to births of fertile pups. These results suggest that fertility may not be impaired after puberty suppression and cross-hormone therapy for transgender males.

News (Medical) associated with Testosterone Cypionate

16 Mar 2023

·www.pharmaceutical-technology.com

Legal challenges put off label use of gender affirming care drugs in jeopardy

Credit: Shutterstock/ Chaos810 Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors. The bill is one of many that are currently being discussed in different states. 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 - 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 Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we 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. Many politicians have cited doubts about the potential “harm” caused by puberty blockers and hormone therapies associated with gender-affirming care and concerns about incorrect treatment as major factors. However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Dr. Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients. Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. This has pushed clinicians to explore different routes to prove the validity of these drugs. The World Health Organization (WHO) defines gender-affirming care as a range of social, psychological, behavioural, and medical interventions that are “designed to support and affirm an individual’s gender identity” when it conflicts with the gender they were assigned at birth. The laws proposed in several bills range in their potential influence; from restricting the prescription of gender-affirming drugs to criminalising the use of such drugs to allowing states to pursue lawsuits against parents who allow children to access such treatments. Dr Lisa Campo-Engelstein, a bioethicist, predicts that these factors and subsequent restrictions on statewide healthcare coverage will heavily restrict patient access to gender-affirming care. Campo-Engelstein is the director of the Institute for Bioethics & Health Humanities at the University of Texas Medical Branch, Galveston. With restricted access and reduced prescription of puberty blockers and hormone therapies, the impact on pharmaceutical companies manufacturing these therapies also remains unclear. Standards of care for gender-affirming therapies The global standards for gender-affirming medical practices stem from the World Professional Association for Transgender Health (WPATH)’s yearly guidelines . WPATH’s recommendations are based on “the best available science and expert professional consensus” to give “safe and effective pathways” for transsexual, transgender, and gender-nonconforming people . WPATH suggests an individualised approach to treating gender dysphoria. Generally, individuals first take on social gender-affirmation changes. Dr Sean Cahill, PhD, the associate editor of the global, peer-reviewed journal LGBT Health, says “for most young people, healthcare provided doesn’t even go beyond that [social affirmation of gender identity], but a lot of people… are misrepresenting what gender affirming care looks like in this country”. Following this, they may progress to the use of puberty blockers. After a minor has been on puberty blockers for two to three years, they may have the option to use hormone therapies upon further evaluation. Puberty blockers are used in gender affirming care to delay the onset of puberty for gender dysphoric children of any gender. These drugs do not tend to have permanent effects and only cause a pause in puberty. While hormone therapies are allowed in the US, the age limit for this is dependent on the geographical area. Standard puberty blockers include Gonadotrophin Releasing Hormone (GnRH) analogues like Trelstar (triptorelin), Supprelin (Histrelin), and Zoladex (Goserelin), are only prescribed off label in the US and UK for gender affirming care. For example, Ontario, Canada-based Verity Pharmaceuticals’s Trelstar was FDA approved for palliative treatment of advanced prostate cancer and the other two are indicated for treating central precocious puberty and endometriosis, respectively. Several companies that produce commonly used puberty blockers such as Vantas Pharmaceuticals, Endo International and TerSera Therapeutics, have remained silent on the ongoing debate. Additionally, hormone therapies—testosterone to “masculinise” and/or transition to men, and oestrogen for transitioning to women and/or “feminising” the body—are an integral part of the plan. Testosterone stops menstrual cycles, decreases the ovaries’ ability to make oestrogen and more, while oestrogen allows individuals to develop breasts, rounder hips and changes to the reproductive system. The most commonly used testosterones in the US include Endo International’s Delatestryl (testosterone enanthate) and Aveed (testosterone undecanoate), and Pfizer’s Depo-testosterone (testosterone cypionate). These changes can be irreversible and can take up to five years to reach maximum effect. Common oestrogen therapies are mostly oestradiols such as Novartis’ Vivelle-Dot, Ascend Therapeutics’ Estrogel, and Teva Pharmaceuticals’ Gynodiol. Oestrogen hormone therapies are often approved for restoring hormone levels for cisgendered women, to reduce symptoms such as hot flushes and vaginal dryness. Dr. Edmund Horowicz PhD, a lecturer in medical law and ethics at the University of Liverpool, counters discourse from those such as the Norwegian Healthcare Investigation Board UKOM , that characterises puberty blockers as “experimental” and untrustworthy due to their off-label prescription. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz. As these drugs are not licensed for the specific indication of gender-affirming care, collecting safety data on off-label use is not viewed as a priority. Cahill says health centers across the nation, like his, see a sizable transgender population, and would be able to easily conduct longitudinal drug studies investigating safety measures and patient satisfaction. But the funding is not there, he adds. The onus for funding would most likely be on government agencies like the National Institutes of Health (NIH), says Cahill. Moreover, there are some logistical barriers in designing such studies. While it is important to run randomised placebo-controlled trials, giving participants sham gender affirming care, for example, would worsen mental distress associated with gender dysphoria, says Horowicz. There might also be ethical considerations for denying care and some subjects may also drop out of studies. Still, while the long-term impact of puberty blockers on bone-density and muscular skeletal development still needs to be studied, Horowicz asserts this should be viewed as a risk associated with a drug, similar to all other drugs. In Georgia’s bill , the legislators reason that the bill would be necessary under the “do no harm” principle, expressing safety concerns for minors. Due to a lack of long-term data into the possible impacts of these drugs, some people have proposed a possible solution of only prescribing these drugs within studies until more data arises. But this would restrict these drugs to only those who choose to be trial participants, creating further ethical conundrums, says Horowicz. Furthermore, Horowicz states that clinical frameworks, such as WPATH’s guidelines, are already based on evidence from trials of these well-established drugs. New studies for this use would be “more to satisfy those who are concerned about the provision of puberty blockers than any kind of traditional expected model of pharmacological research”. Possible consequences Last year, the Biden administration proposed the implementation of a rule in section 1557 , that would protect against limiting access to care by stating that “categorically refusing to provide treatment to an individual based on their gender identity is prohibited discrimination”. However, the recent state-specific gender affirmation legislations may look to contradict this. For example, in Florida, the Agency for Health Care Administration has prohibited Medicaid from covering any kind of gender-affirming care procedures like hormone therapies. Campo-Engelstein says some states like Texas don’t allow coverage for gender-affirming care through public systems. However, she points out that gender affirmation practices are still completely legal in the context of intersex “correction”, yet lawmakers contradict their use for transgender individuals. An immediate consequence of the possible legal ramifications of the bills is a shift in patient care and healthcare coverage, particularly for publicly funded hospitals. A bellwether for which states may see major changes in drug prescription and coverage, may be the ones that saw changes in access to abortion following the Supreme Court overturning Roe v Wade . “States that are banning abortion are going to be more likely to ban gender affirming care, because they’re both motivated by the same social and political values,” says Campo-Engelstein. DeCoster says the lack of consultation with clinicians and patients in deciding these legislations does a disservice to those most affected by the new laws. “We should be having a health care system that is helping support and to raise up people to give them what they need,” he says. 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 Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we 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 Approval

28 Jul 2022

·endpts.com

Manufacturing roundup: GenBioPro looks to counter Mississippi trigger law; Pisgah Labs to invest $55M in NC expansion

As the issues from the Roe V. Wade decision continue to cascade in various circles, including the biotech world , one manufacturer is looking to push back against state law. According to a report from Bloomberg BNN, mifepristone manufacturer GenBioPro is looking to challenge a Mississippi anti-abortion law set into motion by the US Supreme Court’s reversal of Roe v. Wade, stating that the move is keeping its product off the shelves. While Mississippi’s trigger law committed to banning most abortions, it includes abortions relying on pills approved by the FDA such as mifepristone. GenBioPro is now amending its complaint it filed in 2020 in Mississippi to the state to address the trigger law. The case is attempting to push back Mississippi’s mifepristone restrictions, which were in effect before the Roe V. Wade decision, counters FDA regulations over the pill. The company is arguing that FDA dispensing and prescribing regulations for the pill preempt state requirements, including having a licensed physician prescribe the drug in person. Pisgah Laboratories a pharmaceutical manufacturer and subsidiary of India-based Ipca labs, will invest $55 million to expand its manufacturing product line and add 57 new jobs in eastern North Carolina. According to the North Carolina governor’s office, the site originally started producing x-ray film dye and agrochemicals. The company received FDA approval to manufacture APIs in 2002 before exclusively developing pharmaceuticals in 2005. Pisgah manufactures the active ingredients for pain medicines and the treatment of disorders and diseases, such as Alzheimer’s and fibromyalgia. The expansion will also add sterile injectables, liquid filling operations and a quality control laboratory, warehousing and microbiological laboratories. “Our parent company, Ipca Laboratories Limited, is making a large investment in Pisgah’s future. Carving a space in the highly competitive pharmaceutical market is not an easy task, but we welcome the challenge and intend to see many years of company growth, job creation and education opportunities for Pisgah Labs and western North Carolina,” said site manager Dani Bailey. The site also received a performance-based grant of $50,000 from the One North Carolina Fund, which provides financial assistance to local governments to help attract economic investment and create jobs. Companies receive no money upfront and must meet job creation and capital investment targets to qualify for payment. Sun Pharma and Glenmark, two manufacturers of generic drugs, issued a recall over manufacturing issues. According to a report from Fierce Pharma, On June 21, Sun Pharma initiated a voluntary recall of 50,680 vials of testosterone cypionate injection because of “water leakage” at a plant in Gujarat, India. Glenmark recalled over 98,307 packs of mometasone furoate topical solution, a lotion that treats skin conditions such as eczema, psoriasis, allergies and rash. Glenmark started the recall on June 16. The issue for Glenmark was over defective packaging at its plant in Himachal Pradesh, India. Precision NanoSystems (PNI) and Replicate Bioscience are looking to enter into a licensing agreement to accelerate the creation, scale-up and delivery of self-replicating RNA (srRNA) therapies. The agreement will see PNI provide lipid nanoparticle solutions for scale-up and manufacturing of up to 15 Replicate srRNA therapeutics. The terms include aggregated milestone fees, royalties, and sublicensing for income sharing, but the company remained mum on the wider details. “I’m confident in PNI’s delivery technology and our working relationship. With this agreement, Replicate aims to significantly expand our portfolio of srRNA therapeutics beyond our lead candidates slated to enter human trials next year,” said Andy Geall, chief development officer of Replicate. The deal will also allow Replicate to explore more drug candidates in areas beyond the company’s lead programs, which address endocrine therapy resistance in breast cancers, immunotherapy resistance in solid tumors and possibly future pandemics.

Generic DrugImmunotherapy

100 Deals associated with Testosterone Cypionate

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KEGG	Wiki	ATC	Drug Bank
D00957	Testosterone Cypionate	G03BA03	DB13943

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Andropause	-	-	26 Aug 1999
Hypogonadism	-	-	26 Aug 1999
Breast Cancer	-	-	01 Aug 1999
Breast Diseases	-	-	01 Aug 1999
Oligospermia	-	-	23 Jul 1999
Osteoporosis	-	-	18 Jul 1999
Eunuchism	-	-	14 Jul 1999
Delayed Puberty	-	-	12 Jul 1999

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02995330 (CTgov)	Phase 1	Metastatic castration-resistant prostate cancer	3	Bone marrow transplantation+Cytoxan+testosterone cypionate	tnpuawesgt(pjcoejyfkr) = mpbdpxszsf ylfylgefwt (lutlzkqisi, tnoqbuhdkj - fiuszgpddt) View more	-	13 Feb 2024
NCT02090114 (RESTORE, CTgov)	Phase 2	Prostatic Cancer	112	Enzalutamide+Testosterone Enanthate+Testosterone cypionate (Cohort A:Post-enzalutamide)	cgrwxjdpqx(ajmmfygjrr) = lvohlqscti fwljbwtvdm (rukkdbblsl, kvqyryucfd - afymonffvq) View more	-	27 Jun 2022
NCT02090114 (RESTORE, CTgov)	Phase 2	Prostatic Cancer	112	Testosterone Enanthate+Abiraterone acetate+Testosterone cypionate (Cohort B: Post-abiraterone)	cgrwxjdpqx(ajmmfygjrr) = vqdzfzevxu fwljbwtvdm (rukkdbblsl, brguvxemaf - hawczgyuug) View more	-	27 Jun 2022
AUA2021	Not Applicable	Multiple Endocrine Neoplasia	263	Intramuscular Testosterone Cypionate	vhzcwhsqrg(ikdxezukqn) = tuhhoaifjs hxtkdwuyux (hcbdelwtij )	-	01 Sep 2021
AUA2021	Not Applicable	Multiple Endocrine Neoplasia	263	Subcutaneous Testosterone Enanthate	vhzcwhsqrg(ikdxezukqn) = gkxsgqxjoi hxtkdwuyux (hcbdelwtij )	-	01 Sep 2021
NCT02408445 (CTgov)	Phase 4	Klinefelter Syndrome	20	testosterone cypionate 200mg/ml	cqvwxybbon(uylapcdjsn) = hqiqhohalx dayzxzwriw (rwqvbcjkqr, waejqttxzr - irzkgojwcp) View more	-	15 Apr 2020
NCT02286921 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer \| Castration-Resistant Prostatic Cancer	222	Testosterone Enanthate+Testosterone cypionate (Arm A: Testosterone Cypionate or Testosterone Enanthate)	dnmfbrobjc(kojrxjrvki) = xzibfvuiai pftinmdges (jxkcpqtfeg, cfkoncevsy - oclmhtztsu) View more	-	01 May 2019
NCT02286921 (CTgov)	Phase 2		222	Enzalutamide (Arm B: Enzalutamide)	dnmfbrobjc(kojrxjrvki) = nswachgjib pftinmdges (jxkcpqtfeg, khymxbhuim - fjywgwhttn) View more	-	01 May 2019
NCT01750398 (BATMAN study, CTgov)	Phase 2	Recurrent Prostate Carcinoma	33	Testosterone	jxjqrxljyt(mwcczmpnfp) = sfdpvlbrrd laqiucwzio (txqsndpwao, kkamziawgr - mlahreqejt) View more	-	05 Dec 2016

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