Drugs / Testosterone Undecanoate
Testosterone Undecanoate
also known as
Nebido · AVEED · JATENZO · LPCN 1021 · testosteron undecanoate · TLANDO · ABT-SLV361 · Andriol · +8 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypogonadism, male 3 milestones | |||||
| Filed | Other | TLANDO | hypogonadism, male | 2025-06-09 | “today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO ® in Canada.” lipocine.com ↗ |
| Filed | US (FDA) | TLANDO | hypogonadism, male | 2022-02-03 | “the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") resubmission for TLANDO ® (testosterone undecanoate).” lipocine.com ↗ |
| Rejected (CRL) | US (FDA) | TLANDO | hypogonadism, male | 2018-05-08 | “received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for TLANDO™” lipocine.com ↗ “TLANDO received a Complete Response Letter from the FDA on May 8, 2018.” lipocine.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | AVEED | — | 2014-03-05 | fda.gov ↗ |
Trials 53
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06312761 | Jun 2024 → Dec 2025 | hypogonadism, male | University of Washington | Unknown | No outcome recorded |
| Phase 1/2 | NCT03335254 | Nov 2017 → May 2018 | hypogonadism, male | TesoRx Pharma, LLC | Terminated | No outcome recorded |
| Phase 219 trials · 3 met primary | ||||||
| Phase 2 | NCT06082817 | Jan → Dec 2025 overdue | hypoactive sexual desire disorder | San Diego Sexual Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05249634 | Mar 2022 → Jun 2028 expected | chronic kidney disease, hypogonadism, male | St. Louis University | Recruiting | No outcome recorded |
| Phase 2 | NCT05081193 | Mar 2022 → Aug 2025 overdue | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04798469 | Jan 2022 → Sep 2027 expected | hypogonadism, male, substance-related disorder | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04049331 | Mar 2021 → Jan 2027 expected | hypogonadism, male, myalgic encephalomeyelitis/chronic fatigue syndrome | Seattle Institute for Biomedical and Clinical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT03910738 | Oct 2019 → Dec 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 2 | NCT04134091 | Aug 2019 → Jun 2021 | metabolic dysfunction-associated steatohepatitis | Lipocine Inc. | Completed | Met primary |
| Phase 2 | NCT03576001 | Aug 2019 → Jan 2025 | spinal cord injury | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02921386 | Oct 2016 → Jan 2017 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03379012 | Feb 2016 → Jan 2018 | renal cell carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 2 | NCT01919294 | Jul 2013 → Jan 2017 | hypogonadism, male, metabolic dysfunction-associated steatohepatitis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01724658 | Jun 2012 → Apr 2013 | sexual disorder | Chulalongkorn University | Completed | Met primary |
| Phase 2 | NCT01516554 | Feb 2012 → Jan 2014 | multiple sclerosis | Health Sciences Centre, Winnipeg, Manitoba | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00924612 | Jul → Sep 2009 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT00911586 | Jul → Sep 2009 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00695110 | Jun → Dec 2008 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02697188 | Nov 2007 → Apr 2008 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00239590 | Jun 2001 → Apr 2004 | coronary artery disorder | Imperial College London | Completed | No outcome recorded |
| Phase 2 | NCT00452322 | Apr 1997 → Jan 2007 | hypogonadism, male | University Hospital Muenster | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05964920 | Sep 2024 → Dec 2025 | hypogonadism, male | Norwegian School of Sport Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04456530 | May 2020 → Dec 2021 | muscular atrophy | The Stone Research Foundation for Sports Medicine and Arthritis | Unknown | No outcome recorded |
| Phase 2/3 | NCT01206270 | Jun 2009 → Jun 2017 | Klinefelter syndrome, hypogonadism, spermatogenic failure | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 313 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT03198728 | Jul 2017 → May 2020 | hypogonadism, male | Marius Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03242408 | Jan → May 2017 | hypogonadism, male | Lipocine Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03242590 | Dec 2016 → Mar 2017 | hypogonadism, male | Lipocine Inc. | Completed | Met primary |
| Phase 3 | NCT02722278 | Mar → Nov 2016 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02081300 | Feb 2014 → May 2015 | hypogonadism, male | Lipocine Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02514629 | Jul 2013 → Jul 2016 | hypogonadism, obesity disorder | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Completed | No outcome recorded |
| Phase 3 | NCT01765179 | Jan → Jul 2013 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01699178 | Aug 2012 → Apr 2014 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00467870 | Mar 2006 → Jul 2009 | hypogonadism, male | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00146146 | May 2005 → May 2006 | — | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00117000 | Jul 2003 → Feb 2007 | protein-energy malnutrition | University of Adelaide | Unknown | No outcome recorded |
| Phase 3 | NCT00230984 | Apr 2003 → Jun 2008 | nutritional deficiency disease, respiratory failure | University Hospital, Grenoble | Completed | Missed primary |
| Phase 3 | NCT00220298 | Feb 2003 → Oct 2007 | hypogonadism, male | Bayer | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT06385509 | Jul 2024 → Nov 2025 | hypogonadism | Tolmar Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04983940 | Jun 2021 → Apr 2023 | hypogonadism, male | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT04120363 | Sep 2019 → Jul 2021 | — | Pennington Biomedical Research Center | Completed | No outcome recorded |
| Phase 4 | NCT03815331 | Jan 2019 → Dec 2020 | Peyronie disease | Men's Health Boston | Completed | No outcome recorded |
| Phase 4 | NCT03126656 | Sep 2016 → Apr 2017 | heart failure, hypogonadism | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT01092858 | Sep 2010 → Jul 2011 | hypogonadism, male | Bayer | Terminated | No outcome recorded |
| Phase 4 | NCT01852994 | Jul 2009 → Jul 2015 | heart failure | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00710827 | Oct 2008 | hypogonadism | Bayer | Withdrawn | No outcome recorded |
| Phase 4 | NCT00555087 | May 2007 → Jan 2008 | erectile dysfunction, hypogonadotropic hypogonadism | Hospital Santa Fe | Unknown | No outcome recorded |
| Phase 4 | NCT00421460 | Jan 2007 → Jan 2011 | erectile dysfunction, hypogonadism | Chulalongkorn University | Completed | No outcome recorded |
| Phase 4 | NCT00131183 | Sep 2005 → May 2008 | — | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06188767 | Apr 2025 → Dec 2027 expected | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| — | NCT05649605 | Mar 2023 → Dec 2025 overdue | — | Karolinska University Hospital | Recruiting | No outcome recorded |
| — | NCT03995251 | Jul 2019 → Jun 2020 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT05417035 | Jun 2014 → Aug 2019 | delayed puberty, self-limited | NU-Hospital Organization, Sweden | Completed | No outcome recorded |
| — | NCT00119483 | Sep 2005 → Dec 2007 | hypogonadism, male | University Hospital of North Norway | Completed | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 1 | NCT03973840 Background | Jul 2018 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02966652 Comparator | Nov 2016 → Oct 2018 | hypogonadism, male | Neurocrine UK Limited | Completed | No outcome recorded |
| Phase 1 | NCT01346319 Comparator | Apr → Sep 2011 | hypogonadism, male | Abbott | Completed | No outcome recorded |
| Phase 1/2 | NCT02670343 Background | Jan → Mar 2016 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT07512323 Comparator | Aug 2026 → Sep 2029 expected | hypogonadism, male | Rune Skovgaard Rasmussen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT00842751 Comparator | Jul → Nov 2009 | — | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00403793 Comparator | Oct 2003 → Dec 2006 | — | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT00434824 Comparator | Nov 2001 → Jul 2004 | hypogonadism | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/3 | NCT00613782 Comparator | Jan 2009 → Jan 2014 | hypogonadism, type 2 diabetes mellitus | Austin Health | Completed | No outcome recorded |
| Phase 3 | NCT06489457 Comparator | Sep 2020 → May 2023 | hypogonadism, obesity disorder, type 2 diabetes mellitus | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 3 | NCT04545450 Comparator | Nov 2008 → Jul 2009 | hypogonadism | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00696748 Comparator | Oct 2005 → Jan 2009 | hypogonadism, male, metabolic syndrome X | Russian Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT03851627 Comparator | Jan 2022 → Sep 2028 expected | fatty liver disease, hypogonadism, male, obesity disorder, type 2 diabetes mellitus | Alexandra Kautzky-Willer | Recruiting | No outcome recorded |
| Phase 4 | NCT03721497 Comparator | Dec 2020 → Nov 2025 | hypogonadism, male, muscular atrophy | Esbjerg Hospital - University Hospital of Southern Denmark | Completed | No outcome recorded |
| Phase 4 | NCT04456296 Comparator | Jun 2020 → Jul 2023 | hypogonadism, male, hypogonadotropic hypogonadism | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 4 | NCT03792321 Comparator | Jan 2014 → Mar 2015 | hypogonadism, male, obesity disorder, type 2 diabetes mellitus | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT01813201 Comparator | Mar 2011 → Mar 2014 | heart failure | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| — | NCT04134130 Background | Sep → Dec 2019 | prostate cancer | Lund University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Lipocine Inc. | Regulatory Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy lipocine.com ↗
Health Canada has approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). |
| 2025-06-09 | Verity Pharmaceuticals Inc. | Regulatory Lipocine Announces Filing of New Drug Submission for TLANDO ® in Canada veritypharma.com ↗
Lipocine Inc. (NASDAQ: LPCN ), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO ® in Canada. |
| 2025-06-09 | Lipocine Inc. | Regulatory Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO ® in Canada. |
| 2025-03-12 | Lipocine Inc. | Regulatory Lipocine Announces FDA Labeling Changes for Testosterone Products lipocine.com ↗
Based on the TRAVERSE trial results, the FDA has recommended that the Boxed Warning related to an increased risk of adverse cardiovascular outcomes be removed from the labels of testosterone products. |
| 2022-05-12 | Lipocine Inc. | Results Lipocine Announces Positive LPCN 1144 NASH Open Label Extension Study Results lipocine.com ↗
LPCN 1144 was well tolerated over 72-week exposure with no observed safety signals |
| 2022-03-29 | Lipocine Inc. | Regulatory LIPOCINE ANNOUNCES ITS PARTNER RECEIVED FDA APPROVAL OF TLANDO™ lipocine.com ↗
the U.S. Food and Drug Administration ("FDA") has approved TLANDO™ (testosterone undecanoate), an oral treatment for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. |
| 2022-02-03 | Lipocine Inc. | Regulatory LIPOCINE ANNOUNCES ITS PARTNER RECEIVED FDA ACCEPTANCE OF NDA RESUBMISSION FOR TLANDO® lipocine.com ↗ |
| 2022-01-27 | Lipocine Inc. | Results Lipocine Announces Peer-Reviewed Publication of Phase 3 Study Results for TLANDO® lipocine.com ↗
The primary efficacy results confirm that TLANDO administered without dose titration restores testosterone levels to the normal range in hypogonadal men. |
| 2021-11-04 | Lipocine Inc. | Regulatory Lipocine Announces FDA Grants Fast Track Designation to LPCN 1144 for Treatment of Non-Cirrhotic NASH lipocine.com ↗
Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis ("NASH"). |
| 2021-09-28 | Lipocine Inc. | Regulatory Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO® lipocine.com ↗
Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration ("FDA") has affirmed the resubmission of its New Drug Application ("NDA") for TLANDO ® , its oral testosterone product, will be a Class 1 resubmission. |
| 2021-03-04 | Lipocine Inc. | Results Lipocine Announces Publication in Journal of Endocrinological Investigation Highlighting the Potential of LPCN 1144 in the Treatment of NASH and Hepatic Fibrosis lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144 in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. |
| 2020-12-08 | Lipocine Inc. | Regulatory Lipocine Announces Tentative Approval of TLANDO™ lipocine.com ↗
We are pleased to have received this tentative approval for TLANDO. |
| 2020-11-06 | Lipocine Inc. | Regulatory Lipocine Provides Regulatory Update on TLANDO™ lipocine.com ↗ |
| 2020-10-14 | Lipocine Inc. | Results Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗
A majority (81%) of hypogonadal subjects achieved average testosterone levels within the normal range post ~3 weeks of treatment without dose adjustment (95% CI 72% - 88%). |
| 2020-08-28 | Lipocine Inc. | Regulatory Lipocine Provides Regulatory Update for TLANDO™ lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible. |
| 2020-03-04 | Lipocine Inc. | Regulatory Lipocine Announces TLANDO™ PDUFA Date of August 28, 2020 lipocine.com ↗
The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2020 . |
| 2020-02-24 | Lipocine Inc. | Regulatory Lipocine Announces Regulatory Path Forward for TLANDO™ Resubmission lipocine.com ↗
Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. |
| 2019-11-11 | Lipocine Inc. | Regulatory Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA lipocine.com ↗
TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men and received a Complete Response Letter from the U.S. Food and Drug Administration on November 8, 2019 . |
| 2019-09-23 | Lipocine Inc. | Results Lipocine Announces Presentations at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗
Improved Patient Reported Sexual and Mental Domain Outcomes with Oral Testosterone (TLANDO) Relative to Topical Testosterone in Treated Hypogonadal Men |
| 2019-05-14 | Lipocine Inc. | Regulatory Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019 lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") for TLANDO as testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. |
| 2019-03-27 | Lipocine Inc. | Results Lipocine Announces ABPM Labeling Study Results Consistent with Recently Approved Testosterone Replacement Therapy lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced findings from the Ambulatory Blood Pressure Monitoring clinical study (NCT03868059) ("ABPM Study") designed to study TLANDO's effects on blood pressure. |
| 2019-02-14 | Lipocine Inc. | Regulatory Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects lipocine.com ↗
We are pleased with the clearance of our IND to further evaluate LPCN 1144 starting in biopsy confirmed male hypogonadal NASH subjects. |
| 2019-01-24 | Lipocine Inc. | Regulatory Lipocine Files IND To Evaluate LPCN 1144 In Biopsy Confirmed NASH Subjects lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that it has filed an Investigational New Drug application ("IND") with the U.S. Food and Drug Administration ("FDA") to initiate a Phase 2 clinical study of LPCN 1144 in non-alcoholic steatohepatitis ("NASH") with biopsy confirmed NASH subjects. |
| 2018-12-31 | Lipocine Inc. | Results Lipocine Announces Successful Ex Vivo Conversion Assessment of TLANDO™ lipocine.com ↗
The topline results of the study demonstrated that the overall (N=24) mean percentage difference and the associated percentage standard deviation post dose of T concentrations measured between SST samples and PT samples are -1.0% and 9.2%, respectively. |
| 2018-12-20 | Lipocine Inc. | Results Lipocine Announces LPCN 1144 MRI-PDFF Clinical Results Selected for Presentation at Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD lipocine.com ↗
In our study and based on liver fat ≥ 5%, about 70% of hypogonadal patients were identified as having NAFLD suggesting male hypogonadism is an underappreciated comorbidity in NAFLD and NASH, |
| 2018-10-11 | Lipocine Inc. | Results Lipocine Announces LPCN 1144 Clinical Trial Results Selected for Late-Breaker Presentation at The Liver Meeting® 2018 lipocine.com ↗
Oral Testosterone Undecanoate Normalizes Liver Function Measures and Serum Triglycerides in Subjects At-Risk for Non-Alcoholic Fatty Liver Disease ("NAFLD") |
| 2018-05-09 | Lipocine Inc. | Regulatory Lipocine Receives Complete Response Letter for TLANDO From U.S. Food and Drug Administration lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, announced today that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for TLANDO™ |
| 2018-01-10 | Lipocine Inc. | Regulatory Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO™, Testosterone Replacement Therapy in Adult Males with Hypogonadism lipocine.com ↗
voted six in favor and thirteen against the benefit/risk profile of TLANDO |
| 2014-11-24 | Perrigo Company | Regulatory Perrigo Confirms First to File Patent Challenge for Generic Version of Aveed® (Testosterone Undecanoate) Injection perrigo.com ↗
DUBLIN , Nov. 24, 2014 / PRNewswire / -- Perrigo Company plc (NYSE: PRGO; TASE) today announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone undecanoate injection and that it has notified the owner of the Reference Listed Drug of its filing. |
All press releases naming this drug 45 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 75 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Testosterone Undecanoate | “Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according...” NCT03995251 ↗60“Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).” NCT04134091 ↗ “Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively” NCT01092858 ↗ “Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment.” PMID 34994093 ↗ Jan 2022 “TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.” NCT03335254 ↗ “Cross-sex hormone therapy consisting of intramuscular injection of testosterone undecanoate 250mg/ml.” NCT05649605 ↗ “intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma)” NCT00613782 ↗ “Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day” NCT03242408 ↗ “Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days” NCT00842751 ↗ “oral preparation of testosterone undecanoate (TU)” NCT03198728 ↗ “Testosterone Undecanoate (ABT-SLV361)” NCT01346319 ↗ |
| Known as | ABT-SLV361 | “Testosterone Undecanoate (ABT-SLV361)” NCT01346319 ↗ |
| Known as | Andriol | “Oral testosterone undecanoate (Andriol)” NCT00434824 ↗ |
| Known as | AVEED | “Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone).” NCT03815331 ↗4“Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]” NCT04049331 ↗ |
| Known as | BAY86-5037 | “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ |
| Known as | JATENZO | “Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare...” PMID 36272969 ↗ Oct 2022 |
| Known as | LPCN 1021 | “Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day” NCT03242408 ↗2“Oral Testosterone Undecanoate (TU, LPCN 1021)” NCT03242590 ↗ “Oral testosterone undecanoate, LPCN 1021” NCT02081300 ↗ |
| Known as | Nebido | “Inj. Testosterone undecanoat (Nebido®), 1000 mg im or placebo preoperative (baseline, weeks 6, 18 and 30 depending on time to surgery) and postoperative (weeks 4, 16, 28, 40) (Table 1).” NCT03721497 ↗9“Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)” NCT03379012 ↗ “Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection” NCT03910738 ↗ “Nebido (testosterone undecanoate) intramuscular 4 ml by scheme” NCT00696748 ↗ “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ “Nebido (Testosterone Undecanoate)” NCT00119483 ↗ |
| Known as | Nebido (3-oxandrostenderivate), testosterone undecanoate | “Nebido (3-oxandrostenderivate), testosterone undecanoate” NCT05649605 ↗ |
| Known as | NebidoTM | “Testosterone undecanoate (TU) - NebidoTM” NCT00220298 ↗ |
| Known as | Oral TU | “Oral TU” NCT01699178 ↗ |
| Known as | Reandron 1000 | “intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma)” NCT00613782 ↗ |
| Known as | testosteron undecanoate | “Active treatment is Nebido, 1000 mg testosteron undecanoate, a 4 ml intramuscular depot injection.” NCT00119483 ↗1“Contraindications Testosteron undecanoate (ATC-code G03BA03)” NCT03721497 ↗ |
| Known as | Testosterone Undeconate | “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ |
| Known as | Testosterone Undecylate | “Application quarterly of Testosterone Undecylate” NCT01852994 ↗ |
| Known as | Testosterone Undecylate (Nebido) | “Testosterone Undecylate (Nebido)” NCT01852994 ↗ |
| Known as | TLANDO | “The primary objective was the efficacy of oral testosterone undecanoate (TLANDO; Antares Pharma Inc.) in male patients with documented hypogonadism.” PMID 39252657 ↗ Sep 20241“Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment.” PMID 34994093 ↗ Jan 2022 |
| Action | Inhibit | “exogenous testosterone can suppress LH levels” NCT01206270 ↗ |
| Modality | Small molecule | “androgenic steroids” NCT00230984 ↗ |
| Route | Oral | “Oral testosterone undecanoate (40 mg daily for women, 80 mg twice daily for men) and an oral nutritional supplement (475 kcal/d) were administered” PMID 19144729 ↗ Jan 2009 |