Last update 30 Jun 2024

Zuclomifene(Veru Healthcare, Inc.)

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-N,N-diethylethanamine, 2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine, 2-(p-(β-chloro-α-phenylstyryl)phenoxy)triethylamine

+ [10]

Target

Mechanism

ERs agonists(Estrogen receptors agonists)

Therapeutic Areas

Other Diseases

Active Indication

Hot Flashes

Inactive Indication

Advanced Prostate CarcinomaDiffuse Intrinsic Pontine GliomaLymphoma+ [3]

Originator Organization

Veru Healthcare, Inc.

Active Organization

Veru Healthcare, Inc.

Inactive Organization

Actuate Therapeutics, Inc.Startup

Veru, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Structure

Molecular FormulaC32H36ClNO8

InChIKeyPYTMYKVIJXPNBD-OQKDUQJOSA-N

CAS Registry7619-53-6

Clinical Trials associated with Zuclomifene(Veru Healthcare, Inc.)

ACTRN12623000329662 / Not yet recruitingPhase 3

Impact of clomiphene on semen parameters in normogonadotrophic idiopathic male infertility: a double-blind randomised placebo-controlled trial

Start Date01 Nov 2023

Sponsor / Collaborator

Hudson Institute of Medical Research

IRCT20120215009014N417 / SuspendedPhase 3

Comparison of the effect of three drugs clomiphene, letrozole and gonadotropin on the dominant follicle and pregnancy in infertile women with polycystic ovaries: a single-blind randomized controlled trial

Start Date04 Apr 2022

Sponsor / Collaborator

Hamedan University of Medical Sciences

EUCTR2018-004641-16-GB / Unknown statusPhase 3IIT

Letrozole or Clomifene, with or without metformin, for ovulation induction in women with polycystic ovary syndrome: a 2x2 factorial design randomised trial (The LOCI trial) - LOCI: Letrozole Or Clomifene for Ovulation Induction

Start Date14 Feb 2020

Sponsor / Collaborator

University of Birmingham

100 Clinical Results associated with Zuclomifene(Veru Healthcare, Inc.)

100 Translational Medicine associated with Zuclomifene(Veru Healthcare, Inc.)

100 Patents (Medical) associated with Zuclomifene(Veru Healthcare, Inc.)

2,644

Literatures (Medical) associated with Zuclomifene(Veru Healthcare, Inc.)

01 Feb 2024·Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

Protective effects of vanillic acid on letrozole-induced polycystic ovarian syndrome: A comprehensive study in female wistar rats

Article

Author: Jameel Alshamrani, Haya ; V Gadhave, Pradnya ; Imam Rabbani, Syed ; Gilkaramenthi, Rafiulla ; Alobid, Saad ; Abdulrazaq AlAnazi, Majidah ; Das, Kuntal ; Yasmin, Farhana ; Asdaq, Syed Mohammed Basheeruddin ; Sajane, Sachin J ; Redasani, Vivekkumar K ; Ibrahim Almoteer, Ali ; Prasad P, Dharani ; V Sutar, Guruprasad

Background:

Polycystic ovarian syndrome (PCOS) is one of the known causes of anovulatory fertility in the world. Previous research has linked oxidative stress could contribute to PCOS, and vanillic acid has shown antioxidant potential. Hence, the present study evaluated the effect of vanillic acid on letrozole-induced polycystic ovarian syndrome in female rats.

Materials and methods:

PCOS was induced in Wistar female rats with letrozole (1 mg/kg, orally) in carboxymethoxycellulose (1 % w/v), administered for 21 days. After induction, the standard group received clomiphene citrate (1 mg/kg, orally) while other treatment groups were administered with vanillic acid at doses 25, 50, and 100 mg/kg, orally for 15 days, and without treatment was considered a negative control group. Different parameters studied were body weight, ovary weight, blood glucose, lipid profile, hormonal levels [luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone], markers for oxidative stress (superoxide dismutase, reduced glutathione, catalase, and malonaldehyde), and histopathology of the ovary. Statistical analysis was done for the results and p < 0.05 was considered to indicate the significance.

Results:

Vanillic acid-treated animals showed a concentration-dependent activity on the tested parameters. The highest tested dose (100 mg/kg) produced a more prominent effect in significantly (P < 0.001) decreasing the body weight, and ovary weight and improving the hormonal imbalance. Also, vanillic acid significantly (P < 0.01) reduced elevated blood sugar and lipid levels. Additionally, vanillic acid reduced oxidative stress significantly (P < 0.001) in the ovaries of female rats. Histopathological reports showed a reduction in cystic follicles and appearance of normal healthy follicles at different stages of development after the administration of vanillic acid. Furthermore, these effects were observed to be comparable with those recorded for standard drug, clomiphene.

Conclusion:

The current study data suggests that vanillic acid has protected the letrozole-induced polycystic ovarian syndrome. In the event of several side effects associated with conventional treatments used for PCOS, the findings of this study suggest the promising role of vanillic acid. More research in this direction might identify the true potency of vanillic acid in the treatment of PCOS.

01 Feb 2024·Journal of pharmaceutical and biomedical analysis

Testing for clomiphene in keratinous matrices using LC–MS/MS in doping purpose: Is a single intake of clomiphene detectable in hair and nail clippings?

Article

Author: Kintz, Pascal ; Raul, Jean-Sébastien ; Blanchot, Adeline ; Ameline, Alice ; Arbouche, Nadia ; Gheddar, Laurie

Clomiphene is a selective estrogen receptor modulator. It is indicated for the treatment of female infertility issues but in sport, it can be misused to stimulate endogenous testosterone secretion in men. Therefore, it has been prohibited at all times by the World Anti-doping Agency. The aim of this study was to get data to be able to interpret concentrations in athletes. A healthy volunteer (male, 62 years-old) ingested a single therapeutic dose of clomiphene (Clomid™, 50 mg). Strands of hair (blond, 4 cm) were collected one month after the ingestion. Body hair (beard, axillary, pubic and chest hair), and finger and toenails were collected over 4-5 months. A previous method was modified to identify and quantify clomiphene in keratinous matrices. 30 mg of specimen were sonicated and incubated in 1 mL of methanol, in presence of 200 pg of clomiphene-D₅ (internal standard). After centrifugation and evaporation of the organic phase, the samples were analyzed using LC-MS/MS. Linearity was verified in hair and nail clippings between 1 and 500 pg/mg. The limits of detection and quantification were determined at 0.3 and 1 pg/mg respectively. The study demonstrated that clomiphene tested positive in all the analyzed specimens at 9 pg/mg in head hair, from 28 to 486 pg/mg (body hair) and from 4 to 57 pg/mg (nails). Clomiphene was identified for the first time in multiple keratinous matrices. This study demonstrated that a single oral therapeutic dose is detectable in keratinous matrices over a long period of time.

01 Jan 2024·Cell biochemistry and function

The efficacy of Linum usitatissimum seeds to inhibit estrogen receptor as a natural therapy for PCOS: An in silico and in vitro analysis

Article

Author: Hussain, Hafiza A ; Shakeel, Alishba ; Raza, Syed A ; Ahmed, Abrar ; Ahmad, Fatima

Abstract:

Polycystic ovarian syndrome (PCOS) is an endocrinological disorder aroused due to hormonal disturbances. It is characterized by anovulation due to an excess of androgen and estrogen hormones, thus leading to the formation of multiple cysts, imposing life‐threatening conditions. This manuscript aimed to introduce a natural estrogen receptor (ESR) inhibitors that can provide protection against PCOS. The computational analysis of Linum usitatissimum seeds compounds against ESR alpha receptor was performed, and the binding affinities of the ligand compounds and receptor proteins were scrutinized. Nine lignin compounds were docked, and the results were compared with that of reference estrogen receptor inhibitors, clomiphene, and tamoxifen. The binding affinity scores for pinoresinol, lariciresinol, secoisolariciresinol, and matairesinol were −10.67, −10.66, −10.91, and −10.60 kcal mol−1, respectively. These were comparable to the binding affinity score of reference compounds −11.406 kcal mol−1 for clomiphene and −10.666 kcal mol−1 for tamoxifen. Prime MM‐GBSA studies showcased that Linum usitatissimum seeds compounds exhibit significant efficacy and efficiency towards receptor protein. Moreover, MD‐simulation studies were performed and the results depict that the lignin compounds form stable complexes at 300 K throughout the simulation time. For further clarity, in‐vitro experiments were carried out. The results exhibit the decline in cell proliferation in a concentration‐dependent manner by extract 1 (ethyl acetate) EX1 and extract 2 (petroleum ether) EX2. Hence, providing evidence regarding the anti‐estrogenic activity of the sample extracts. Collectively, these results showed that flax seed can reduce the levels of estrogen, which can induce ovulation and prevent cyst formation, and ultimately can provide protection against PCOS.

News (Medical) associated with Zuclomifene(Veru Healthcare, Inc.)

23 Mar 2023

·www.pharmaceutical-technology.com

New medications for PCOS slowly edge toward development

Credit: Shutterstock/justesfir Polycystic ovarian syndrome (PCOS), sometimes known as polycystic ovarian disease (PCOD), is a common endocrine disorder experienced by approximately 5 to 13% of people of reproductive age worldwide. While lifestyle modifications play a key role in treating PCOS, the paucity of new treatments signal a need for breakthrough research. 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 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. Research states that PCOS is typically characterized by hyperandrogenism, high levels of androgens; ovulatory dysfunction; and polycystic ovaries. Scientific research and a better understanding of the condition is driving new developments in medications. ”The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says. A growing body of research also highlights the condition’s impact on quality of life and mental wellbeing. It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. Unmet need for PCOS medications With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a handful of standard drugs. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%). GlobalData is the parent company of Pharmaceutical Technology. Standard medications used for the disorder have also raised questions over their ability to meet the condition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patients, the therapies they take don’t fully address their disease,” details Szwarcberg. While the number of new investigational therapies specifically designed to treat PCOS is scant, some companies continue to repurpose hormonal medications. Florham Park, New Jersey-based Exeltis Pharmaceuticals is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen. Current treatment options mainly address symptoms such as hyperandrogenemia, irregular menstruation, and infertility, and therefore support patients with functional ovarian hyperandrogenism (FOH), which is estimated to affect around 62% of patients with PCOS. With tildacerfont, Spruce aims to target PCOS patients with mixed pathology and primary functional adrenal hyperandrogenism (FAH), which are collectively experienced by approximately 30% of patients who have exaggerated levels of dehydroepiandrosterone sulphate (DHEAS), a type of androgen. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition. Spruce is currently studying the safety and efficacy of tildacerfont in a Phase II study (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The study’s results are anticipated for release in mid-2023. The idea that high adrenal androgen levels in women with PCOS could also be related to an increase in corticotropin (ACTH), a hormone released by the pituitary gland, has long been explored in this space. Using tildacerfont, which also acts as a modulator of ACTH release, Spruce aims to determine if modulating the amount of ACTH regulates the amount of adrenal androgens present in the context of PCOS. Research indicates that increased adrenal androgen production can result in cystic acne, hirsutism, male-type baldness, menstrual irregularities, oligoovulation or anovulation, infertility, and/or frank virilization. Conventional therapies don’t often address the management of hyperandrogenemia in the context of PCOS patients, says Szwarcberg. “We believe this study will provide information around biology and create the foundations by which a program can then be built around the potential benefits in hyperandrogenemia control.” Other novel therapeutic modalities for the management of PCOS include the use of newer insulin sensitizers viz, glucagon-like peptide-1(GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors, says Sayeed Akhtar, PhD, assistant professor, Department of Clinical Pharmacy at King Khalid University, Abha, Saudi Arabia. A research study found that Novartis’s aromatase inhibitor Femara (letrozole) currently appears to be more effective than clomiphene citrate, a common reference drug, in treating infertility caused by PCOS. The incidence of infertility in women with this condition varies between 70–80%, research has found. Managing PCOS symptoms The heterogeneous nature of metabolic and endocrine disorders is a key factor influencing the health sector’s ability to advise and provide specific guidance for managing PCOS. US educational platform Uterinekind has teamed up with the Cornell Ovary Lab to fund research on the condition and has developed an app to help people access resources and support their uterine health. Global healthcare better supports patients in managing their symptoms by “managing the different facets of issues developed due to PCOS”, says Akhtar. Making lifestyle changes is often the first line of treatment before the addition of an insulin-sensitizing drug may be advised. More research is needed. “[PCOS] is a difficult disease to address and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” says Szwarcberg. Commenting on why there is so little research despite the high incidence, Akhtar says this is due to “less focus on policy and funding”. A 2021 UK parliamentary discussion on PCOS and endometriosis stated it did not have plans to increase near-term funding, despite calls for support . Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS. 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.

Phase 2Phase 3

15 Mar 2023

·www.biospace.com

Veru Moves Forward with Late-Stage COVID Study Despite FDA Roadblock

Pictured: FDA sign in front of building/Courtesy Sarah Silbiger/Getty Images Weeks after the FDA rejected Veru’s Emergency Use Authorization (EUA) bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug. Veru will conduct a Phase III study of sabizabulin in hospitalized patients with moderate to severe COVID-19 who are at high risk of developing acute respiratory disease syndrome (ARDS). The drug will also enter a Phase III study in hospitalized influenza patients at risk of ARDS. This announcement in an SEC filing posted Tuesday comes almost two weeks after the FDA turned down sabizabulin’s EUA. On Mar. 2, the company said the regulator rejected the application but remained open to working with Veru on the drug’s development. Concurrent with the rejection, the regulator also provided feedback on Veru’s proposed protocol for a confirmatory Phase III study for sabizabulin, stating that the company should provide “appropriate time frames for interim analyses.” This will allow Veru to end the trial promptly “should a strong efficacy signal again be observed,” according to the FDA. This confirmatory trial could potentially support a new EUA bid or a New Drug Application approval for sabizabulin, according to Veru’s announcement. Sabizabulin is an investigational oral microtubule disruptor that binds to a protein called tubulin, an integral part of the cell’s cytoskeleton. In COVID-19, sabizabulin inhibits the transport of viral particles within the cells and stops the virus from replicating and assembling itself. This mechanism of action also has therapeutic potential in cancer because it disables the formation of the mitotic spindle, preventing the uncontrolled division of tumor cells. However, in Monday’s SEC filing, Veru also announced it was limiting sabizabulin’s clinical development to only infectious disease indications. As a result, it’s discontinuing the Phase III VERACITY study, intended to evaluate the drug in certain prostate cancers. Cost-Cutting and Realignment Along with its plans to pursue Phase III in COVID-19, Veru announced Monday initiatives to “refocus its drug development efforts on those drug candidates” most likely to yield “long-term success.” The company is also implementing cost-cutting measures to conserve cash, including “a reduction in personnel,” the SEC filing read. As for its pipeline, Veru is also updating a Phase III study of its enobosarm, a selective androgen receptor agonist, in combination with abemaciclib, a CDK 4/6 inhibitor, in specific types of metastatic breast cancer. This drug combo is being developed in partnership with Eli Lilly. Veru is also developing enobosarm as a monotherapy in bone-only metastatic breast cancers, with a Phase II study currently planned. Meanwhile, the company is pausing the development of Veru-100, being trialed for prostate cancer, and zuclomiphene, its candidate for hot flashes associated with androgen deprivation therapy.

Phase 3Phase 2Emergency Use Authorization

09 Feb 2023

·www.biospace.com

Veru Reports Fiscal 2023 First Quarter Financial Results

Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies Presented late-breaker oral presentation at IDWeek; sabizabulin treatment resulted in 81.2% relative reduction in deaths compared to the placebo in the WHO 4 subset group Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update. “We have been busy seeking emergency authorization for sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS with major global regulatory bodies,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Our U.S. and international commercial teams are on standby. We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies. Further, we have put in place a multi-pronged strategy to increase revenues from our sexual health program which appears to be successful as Q2 FY 2023 sales are significantly improving. As we await regulatory decisions, we have implemented measures to prudently conserve our cash, and we will provide an update once we are able to determine our path forward.” Infectious Disease Program Updates Sabizabulin, a Novel OralMicrotubule Disruptor, for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) Sabizabulin for the treatment of COVID-19 is currently under regulatory review for potential emergency authorization by U.S. Food and Drug Administration (FDA), European Union’s European Medicines Agency (EMA), United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, South Korea’s Ministry of Food and Drug Safety (MFDS), and Switzerland’s Swissmedic. With respect to Europe, if the EMA authorizes sabizabulin for emergency use under Article 18, then individual EU nations may decide to authorize sabizabulin in their respective countries. In October 2022, Phase 3 data of sabizabulin for the treatment of COVID-19 was presented as a late-breaker at IDWeek (Infectious Disease Week) 2022. Clinical highlights from the presentation include statistically and clinically significant reductions in mortality with sabizabulin treatment resulting in a 22.4 absolute percentage point and 81.2% relative reduction in deaths compared to the placebo (p=0.0090) in a subset analysis of hospitalized moderate to severe WHO-4 COVID-19 patients at high risk for ARDS. Oncology Program Updates Enobosarm, a Novel Oral Selective Androgen Receptor Targeting Agonist, and Abemaciclib, a CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer Enrollment has been ongoing in the Phase 3 multicenter, open label, randomized (1:1), active control ENABLAR-2 trial to evaluate the combination of enobosarm and abemaciclib for the treatment of AR+ER+HER2- metastatic breast cancer. We have a collaboration and supply agreement with Eli Lilly and Company for this trial. Enobosarm for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer Enrollment has been ongoing in the Phase 3 multicenter, international, open label, randomized (1:1) ARTEST trial to evaluate enobosarm for the treatment of AR+ER+HER2- metastatic breast cancer. Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer Enrollment has been ongoing in the Phase 3 VERACITY open label, randomized (2:1), multicenter trial to evaluate sabizabulin 32mg for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have tumor progression after previously receiving at least one androgen receptor targeting agent. VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer Enrollment has been ongoing in the Phase 2 clinical dose finding trial to evaluate VERU-100 for the treatment of androgen deprivation therapy in patients with advanced prostate cancer. Urev - Sexual Health Program Updates FC2 Female Condom/Internal Condom® The Company markets and sells the FC2 Female Condom®, an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. ENTADFI™ (finasteride and tadalafil) capsules for oral use, a New Treatment for Benign Prostatic Hyperplasia (BPH) The Company markets ENTADFI™, an FDA-approved oral, once daily product for benign prostatic hyperplasia (BPH) for men with an enlarged prostate experiencing the signs and symptoms of BPH for up to 26 weeks. First Quarter Financial Summary: Fiscal 2023 vs Fiscal 2022 Net revenues decreased to $2.5 million from $14.1 million Gross profit decreased to $0.7 million from $11.8 million Research and development expenses increased to $18.7 million from $10.1 million Selling, general and administrative expenses increased to $17.5 million from $6.7 million Operating loss was $35.6 million versus $5.0 million Net loss was $36.8 million, or $0.46 per share, compared to $6.4 million, or $0.08 per share Balance Sheet Information Cash and cash equivalents were $46.9 million as of December 31, 2022 versus $80.2 million as of September 30, 2022 Net accounts receivable were $3.9 million as of December 31, 2022 versus $3.6 million as of September 30, 2022 Event Details The audio webcast will be accessible under “Investor Kit” in the Investors page of the Company’s website at . To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on February 9, 2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) passcode 9127050 for one week. About Veru Inc. Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology. The Company’s infectious disease development program includes sabizabulin, an oral microtubule disruptor, for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). In the final analysis of the Phase 3 trial, treatment with sabizabulin 9 mg once daily resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths compared to placebo. Sabizabulin for COVID-19 is currently under regulatory review for potential emergency or conditional authorization by U.S. FDA, European Union’s EMA, United Kingdom’s MHRA, Australia’s TGA, Canada’s Health Canada, South Korea’s MFDS, and Switzerland’s Swissmedic. The Company’s breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin. Veru’s oncology program also includes product candidates in development for the treatment of prostate cancer: sabizabulin, VERU-100, a long-acting GnRH antagonist and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist. The Company’s commercial sexual health program, Urev, has 2 FDA-approved products, including FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections, which is sold in the U.S. and globally and ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia. Forward-Looking Statements The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether the Company will successfully develop or commercialize any drug in the infectious disease area and whether any such drug will serve a potentially life-saving unmet need; whether the Company’s infections disease franchise will generate any commercially available product and whether it will expand sabizabulin or any other compound beyond the potential treatment of certain COVID-19 patients; whether and when the Company will receive an emergency use authorization or any approval from FDA or from any regulatory authority outside the U.S. for sabizabulin for certain COVID-19 patients; whether and when sabizabulin will become an available treatment option for certain COVID-19 patients in the U.S. or anywhere outside the U.S.; whether any additional efficacy or safety clinical studies of sabizabulin for certain COVID-19 patients will be required by the FDA or any other regulatory authority as a condition to any authorization or as a post-authorization requirement; whether the Company will have sufficient supply of sabizabulin or sufficient commercial resources to meet demand, if an emergency use authorization or other approval is granted in the U.S. or in any other country; whether the Company will secure any advance purchase agreement with any government; whether the current and future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of any of the Company’s other drug candidates; whether the drug candidates will be approved for the targeted line of therapy; the anticipated design and scope of clinical studies and FDA acceptance of such design and scope; whether any regulatory pathways, including the accelerated Fast Track designations, to seek FDA approval for sabizabulin, enobosarm or any of the Company’s drug candidates are or will continue to be available; whether the expected commencement and timing of the Company’s clinical studies, including the Phase 3 ENABLAR-2 study, the sabizabulin monotherapy Phase 2b clinical study for 3rd line treatment of metastatic breast cancer, and the Phase 2 registration clinical study for VERU-100 will be met; when clinical results from the ongoing clinical studies will be available, whether sabizabulin, enobosarm, VERU-100, or zuclomiphene will serve any unmet need or, what dosage, if any, might be approved for use in the U.S. or elsewhere, and also statements about the potential, timing and efficacy of the rest of the Company’s development pipeline, and the timing of the Company’s submissions to FDA and FDA’s review of all such submissions; whether ENTADFI will be commercialized successfully, the Company will grow sales of ENTADFI or the Company will be able to successful partner with any other entity to grow sales of ENTADFI; whether the telemedicine customers for FC2 will return to historical ordering patterns or increase their purchases of FC2 at all; whether the Company’s current cash will be sufficient to fund its planned or expected operations, especially if any authorizations for sabizabulin for certain COVID-19 patients are not obtained and whether the Company may need to raise capital; and whether any of the specified clinical trials will be suspended, modified or terminated as the Company seeks to conserve cash. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company’s existing products, including FC2 and ENTADFI and, if authorized, sabizabulin, and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical studies, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to successfully commercialize any of its products, if approved; risks relating to the Company's development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, and development costs; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2022 and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at The Company disclaims any intent or obligation to update these forward-looking statements. Investor Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Media Contact: Hannah Gendel Manager, Corporate Communications Email: media@verupharma.com FINANCIAL SCHEDULES FOLLOW Veru Inc. Condensed Consolidated Balance Sheets (unaudited) December 31, September 30, 2022 2022 Cash and cash equivalents $ 46,927,187 $ 80,190,675 Accounts receivable, net 3,864,310 3,550,895 Inventories, net 8,732,627 8,618,944 Prepaid expenses and other current assets 13,484,521 12,408,960 Total current assets 73,008,645 104,769,474 Plant and equipment, net 1,425,970 1,185,766 Operating lease right-of-use assets 4,600,783 4,786,915 Deferred income taxes 13,052,163 12,965,985 Intangible assets, net 3,959,524 3,977,381 Goodwill 6,878,932 6,878,932 Other assets 856,435 1,561,564 Total assets $ 103,782,452 $ 136,126,017 Accounts payable $ 10,566,962 $ 22,003,394 Accrued research and development costs 12,678,176 9,071,503 Accrued expenses and other current liabilities 15,146,618 9,193,637 Residual royalty agreement liability, short-term portion 1,688,691 1,169,095 Total current liabilities 40,080,447 41,437,629 Residual royalty agreement liability, long-term portion 10,550,764 9,656,441 Operating lease liability, long-term portion 3,963,202 4,093,667 Other liabilities 89,181 99,644 Total liabilities 54,683,594 55,287,381 Total stockholders' equity 49,098,858 80,838,636 Total liabilities and stockholders' equity $ 103,782,452 $ 136,126,017 Veru Inc. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended December 31, 2022 2021 Net revenues $ 2,507,794 $ 14,135,132 Cost of sales 1,805,739 2,293,050 Gross profit 702,055 11,842,082 Operating expenses: Research and development 18,744,349 10,081,161 Selling, general and administrative 17,545,865 6,723,206 Total operating expenses 36,290,214 16,804,367 Operating loss (35,588,159 ) (4,962,285 ) Non-operating expenses (1,322,298 ) (1,303,066 ) Loss before income taxes (36,910,457 ) (6,265,351 ) Income tax (benefit) expense (68,278 ) 114,655 Net loss $ (36,842,179 ) $ (6,380,006 ) Net loss per basic and diluted common shares outstanding $ (0.46 ) $ (0.08 ) Basic and diluted weighted average common shares outstanding 80,558,670 80,023,168 Veru Inc. Condensed Consolidated Statements of Cash Flows (unaudited) Three Months Ended December 31, 2022 2021 Net loss $ (36,842,179 ) $ (6,380,006 ) Adjustments to reconcile net loss to net cash used in operating activities 6,407,640 2,650,481 Changes in operating assets and liabilities (4,099,489 ) (4,928,267 ) Net cash used in operating activities (34,534,028 ) (8,657,792 ) Net cash (used in) provided by investing activities (285,565 ) 2,197,791 Net cash provided by financing activities 1,556,105 204,427 Net decrease in cash (33,263,488 ) (6,255,574 ) Cash at beginning of period 80,190,675 122,359,535 Cash at end of period $ 46,927,187 $ 116,103,961

Phase 3Clinical ResultFinancial StatementPhase 2Fast Track

100 Deals associated with Zuclomifene(Veru Healthcare, Inc.)

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KEGG	Wiki	ATC	Drug Bank
-	Zuclomifene(Veru Healthcare, Inc.)	-	DB00882

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Phase 2	US	Veru, Inc.	14 Sep 2018
Prostatic Cancer	Phase 2	US	Veru, Inc.	14 Sep 2018
Vasomotor symptom	Phase 2	US	Veru, Inc.	14 Sep 2018
Hot Flashes	Phase 2	US	Veru, Inc.	14 Sep 2018
Diffuse Intrinsic Pontine Glioma	Phase 1	US	Actuate Therapeutics, Inc.Startup	05 Jun 2020
Lymphoma	Phase 1	US	Actuate Therapeutics, Inc.Startup	05 Jun 2020
Neuroblastoma	Phase 1	US	Actuate Therapeutics, Inc.Startup	05 Jun 2020

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2023	Not Applicable	Low testosterone levels	-	Clomiphene	mxwwtepnrm(kvuaclmqsg) = mieenpjvwv egataeyorn (pdwjxvundx ) View more	-	01 Apr 2023
				Enclomiphene	mxwwtepnrm(kvuaclmqsg) = gnajlmffxc egataeyorn (pdwjxvundx ) View more
MP58-05 (AUA2019)	Not Applicable	-	143	25mg clomiphene every other day	bjtxtdeugg(lqumxhombl) = filwtaoezl wzvczfkbmh (vozzyizgig ) View more	-	01 Apr 2019
				50mg clomiphene every other day	bjtxtdeugg(lqumxhombl) = unbipkohys wzvczfkbmh (vozzyizgig ) View more
MP74-20 (AUA2015)	Not Applicable	Infertility	307	CLOMIPHENE (Young patients)	fnwvozkjln(ebndmylceu) = wxatwnojki ywahvzvkqg (mdypgtdtvv )	-	01 Apr 2015
				CLOMIPHENE (Patients with normal BMI)	fnwvozkjln(ebndmylceu) = styikbiepd ywahvzvkqg (mdypgtdtvv )
NCT00795808 (PCOSMIC, Pubmed \| Hum Reprod)	Phase 4	Polycystic Ovary Syndrome	171	Metformin	ptjocrbfpl(avdxmuispj) = bxbxhbmzca gcamoizbze (ajcbortecj ) View more	-	01 Jul 2010
				Placebo	ptjocrbfpl(avdxmuispj) = rhmleygxbg gcamoizbze (ajcbortecj ) View more

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