Vasostrict (vasopressin injection) / Endo - LARVOL DELTA

Melatonin as a possible stimulus to unmask an oxytocin deficient state in hypopituitarism and hypothalamic damage (ESPE-ESE 2025) - P=N/A | "Similar results were found in the subgroup of patients with HHD and arginine vasopressin deficiency (AVP-D) (n=17), with HC showing a greater OXT increase at T90 (HC 68.95±4.37 vs. AVP-D 55.52±6.85 pg/mL; difference 13.30 pg/mL, 95%CI 0.95 to 25.65, p=0.03)... The reduced OXT response to melatonin in HHD, supports the existence of an impaired OXT response in a subset of patients with HHD. The associations between OXT changes and psychopathology suggest its role in mood and QoL. These findings provide support for a clinically significant OXT-deficient state in HHD."

CNS Disorders • Depression • Endocrine Disorders • Mood Disorders • Psychiatry • OXT

Development and Validation of a Novel Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) Method for the Quantification of Related Substances of Vasopressin Injection: A Characterization and Comparative Analysis of Vasopressin Formulation Samples against Vasostrict (RLD) in Various Diluents. (PubMed, Ann Pharm Fr) - "The unknown impurities were eluting at RRT 1.23 and RRT 1.25 in the RS methodology (HPLC-UV) of VPS injection are identified and assessed the impurity levels. Furthermore, aggregate profiles and secondary structure analysis studies were carried out using FTIR and LC-HRMS, comparing the VPS formulation samples with the Reference Listed Drug (RLD) (Vasostrict) samples across various diluents."

Journal • Cerebral Hemorrhage

Melatonin as a possible stimulus to unmask an oxytocin deficient state in hypopituitarism and hypothalamic damage. (PubMed, J Clin Endocrinol Metab) - P=N/A | "The reduced OXT response after melatonin in HHD, supports the existence of an impaired OXT response at least in a subset of patients with HHD. The associations between OXT changes and psychopathology suggest its role in mood and QoL. These findings support further investigation into melatonin's role as a diagnostic tool to address OXT-D."

Journal • CNS Disorders • Depression • Endocrine Disorders • Mood Disorders • Psychiatry

TEXAS: Tranexamic Acid in Vaginal Reconstructive Surgery (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: The University of Texas Medical Branch, Galveston | N=36 ➔ 0 | Trial completion date: Mar 2026 ➔ Jan 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2025 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal

Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial. (PubMed, Sci Rep) - P4 | "Identifying a reliable diagnostic test for OXT-D remains crucial. Alternative provocative tests or biomarkers should be explored."

Clinical • Journal • Endocrine Disorders • Sexual Disorders

Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India (Canada Newswire) - "Endo, Inc...announced today that the U.S. Food and Drug Administration (FDA) has approved commercial production of VASOSTRICT (vasopressin injection, USP) at the company's newest aseptic manufacturing facility in Indore, India. The 20,000-square-foot site increases Endo's sterile injectable production capacity and expands the future growth potential for its Injectable Solutions business....This is the Indore facility's first U.S. FDA approval. Endo plans to apply for additional product approvals at the site, and the company estimates that production at the Indore facility will begin in 2026."

FDA event • Hypotension • Novel Coronavirus Disease

Trends and Outcomes in Pituitary Apoplexy Management: A Spanish Observational Multicenter Study. (PubMed, Neurosurgery) - "Although conservative management increased in the last years, surgery remains the predominant option. Patients managed conservatively experience a lower risk of permanent arginine vasopressin deficiency, and a high proportion exhibit clinically significant tumor shrinkage over time."

Clinical • Journal • Oncology • Pituitary Gland Carcinoma

A 31-year referral center experience in pediatric growth hormone secreting pituitary adenomas (ESPE 2024) - "The most frequent complications were arginine-vasopressin deficiency (10%) and cerebrospinal fluid fistula (10%)... Growth hormone excess is a rare condition, with high life-quality impact in pediatric patients, affecting their growth and development in the long term. Our center has a well established pituitary specific multidisciplinary team. The data here presented offers a contribution to national and international epidemiology for the continuous improvement and optimization of the management of these patients."

Clinical • Acromegaly • Endocrine Cancer • Endocrine Disorders • Genetic Disorders • Oncology • Pain • Pediatrics • Pituitary Gland Carcinoma

Adipsic arginine vasopressin deficiency: challenges in managing the intricate interplay of adipsia with polyuria. (PubMed, BMJ Case Rep) - "These individuals develop severe dehydration and hypernatraemia, necessitating multiple emergency visits despite the administration of arginine vasopressin analogue (desmopressin). The treatment monitoring was done using total body weight and weekly to fortnightly serum sodium. Using this approach, the serum sodium was maintained in the range of 140-150 mmol/L, and there were no emergency visits for hypernatraemia or hyponatraemia (dysnatraemia) at 3 months."

Journal • Brain Cancer • CNS Tumor • Endocrine Disorders

Use of Vasopressin Following the Fontan Operation (clinicaltrials.gov) - P2/3 | N=12 | Completed | Sponsor: Advocate Health Care | Withdrawn ➔ Completed

Trial completion • Respiratory Diseases

Pituitary Apoplexy: Comorbidities, Management and Outcomes. A Spanish Observational Multicenter Study. (PubMed, J Clin Endocrinol Metab) - "There is a high burden of cardiovascular risk factors among patients with PA suggesting that metabolic factors may play a potential role in the development of PA. This underscores the need for comprehensive management of these conditions in addition to treating the apoplexy itself in this population. Surgical management has a relevant place in PA approach mainly in patients with higher PAS. However, it leads permanent vasopressin deficit more frequently than conservative approach."

Clinical • Journal • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Oncology • Pituitary Gland Carcinoma

TEXAS: Tranexamic Acid in Vaginal Reconstructive Surgery (clinicaltrials.gov) - P4 | N=36 | Not yet recruiting | Sponsor: The University of Texas Medical Branch, Galveston

New P4 trial • Surgery

Intranasal Vasopressin Treatment in Children With Autism (clinicaltrials.gov) - P2/3 | N=108 | Completed | Sponsor: Stanford University | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Mar 2024

Trial completion • Trial completion date • Autism Spectrum Disorder • Genetic Disorders

Intranasal Vasopressin Treatment in Children With Autism (clinicaltrials.gov) - P2/3 | N=108 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting

Enrollment closed • Autism Spectrum Disorder • Genetic Disorders

Angiotensin II vs. Vasopressin in Septic Shock (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: University of New Mexico | N=40 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Septic Shock

Use of Vasopressin Following the Fontan Operation (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Advocate Health Care | N=84 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal • Respiratory Diseases

IS DESMOPRESSIN USEFUL IN THE EVALUATION OF CUSHING'S SYNDROME? (PubMed, J Clin Endocrinol Metab) - "The distinct expression of the various arginine vasopressin receptors between normal pituitary, corticotroph tumors, or neuroendocrine tumors cells secreting ACTH ectopically suggested that this test could facilitate the etiological diagnosis of ACTH-dependent Cushing's syndrome. Desmopressin response can also be a marker of the risk of longer-term postoperative recurrence. However, this review also highlights the lack of consensual criteria of normal or abnormal response to desmopressin in its various uses and requirement for further research on its usefulness."

Journal • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor

"$ENDP Endo Announces Launch of Ready-to-Use VASOSTRICT® (vasopressin injection, USP) in Pre-Mix Bottles https://t.co/T5xDb8uSG1" (@stock_titan)

Pilot RCT of Angiotensin II vs. Vasopressin in Septic Shock (clinicaltrials.gov) - P4; N=40; Not yet recruiting; Sponsor: University of New Mexico

Clinical • New P4 trial • Septic Shock

"$ENDP Endo Comments on Non-Infringement Ruling in VASOSTRICT® Patent Litigation https://t.co/eGcdWbq5Iv #patent" (@stock_titan)

Eagle Pharmaceuticals Announces FDA Maintains Prioritization of ANDA for Vasopressin (Businesswire) - "...the U.S. Food and Drug and Administration ('FDA') has maintained Priority Review for the Company’s Abbreviated New Drug Application ('ANDA') for vasopressin. The Company’s response to the CRL was submitted on June 15, 2021. The FDA has assigned a GDUFA date of December 15, 2021, and the Company expects a commercial launch prior to year-end. 'Vasopressin is an important program for us, and in light of the Priority Review, as well as its being flagged as a COVID priority, we continue to believe that we can bring this product to market this year. The trial is set to commence on July 7, and we look forward to providing updates in the near future,'..."

ANDA • Launch US • Infectious Disease • Novel Coronavirus Disease