The preparation of several 17-alkyl-17-deoxy steroids of the corticoid series is described.The 17-alkyl group was introduced via Li-liquid ammonia treatment of 3β-acetoxy-5α-pregna-9(11),16-dien-20-one (I) followed by appropriate alkylation.Methyl groups at the 16α and 17α positions were introduced by a procedure involving 1,4 addition of MeMgI to the Δ16-20-oxo system of I, or its corresponding 3-tetrahydropyranyl derivative, followed by methylation of the 16α-methyl-17-enolate anion thus generated.Further elaboration of the resulting 17-alkyl derivatives was carried out by standard procedures.Of particular interest is the synthesis of the 17-methyl and 17-ethyl derivatives of 17-deoxy-9α-fluoroprednisolone 21-acetate and of 17-deoxy-17-methyldexamethasone 21-acetate (II).26 references.

01 Nov 1965·Minerva dermatologica

[On the topical use of a new pharmacological association of enzymes, neomycin and hydrocortamate. Clinical contribution].

Article

Author: Agati, R ; Papalia, L

01 Jan 1961·Japanese circulation journal

The Effects of Hydrocortisone (11-Dehydro-17-Hydroxycorticosterone-21-Acetate) on the Experimental Pulmonary Edema

Article

Author: YONEYAMA, Takeshi

Among the various methods proposed for the treatment of acute pulmonary edema, there has been known no definitive method to inhibit permeability of the pulmonary capillaries. On the basis of abilities of adrenocorticoids- to inhibit capillary permeability and to reduce capillary fragility, the author conducted a series of clinical investigations and proved their efficacy. Hydrocortisone was tested for its therapeutic value in experimental pulmonary edema of different pathophysiology produced by three different techniques. A) Materials and Methods 1) Nerogenic pulmonary edema by Reilly phenomenon. (Stimulation of cervical sympathetics in rabbits.) 2) ANTU pulmonary edema in rats. 3) Post-operative acute pulmonary edema produced by the sequence of pneumonectomy, anoxia then intravenous infusion in dogs. B) Methods of administering hydrocortisone. In groups 1 and 2, hydrocortisone 3 mgm per kilogram of body weight was given prophylactically one hour prior to the start of the procedure to produce pulmonary edema. In group 3, hydrocortisone 3 mgm per kilogram of body weight was given by intravenous infusion together with IPPB/i O2 at the establishment of pulmonary edema. A group of dogs was treated with IPPB/i O2 alone as a control. C) Evaluation of therapeutic efficacy. Therapeutic efficacy was compared among the groups mainly on the basis of pathological findings, macroscopically, histologically and by water content of the lungs, upon sacrificing. In addition. prolonged survival time was taken into account in group 2. In group 3, such parameters as respiratory and circulatory functions (pulse rate, femoral arterial pressure, central venous pressure, pulmonary arterial pressure, pulmonary capillary pressure, oxygen saturation and microscopic observation of the omental capillary vessels) as well as X-ray findings of the chest were also considered. Result and Conclusion 1) Excessive stimulation of the cervical sympathetic nerves caused marked congestion in the pulmonary capillaries, hemorrhage and edema into alveoli in rabbits. Hydrocortisone given prophylactically in a dose of 3 mgm. per kilogram of body weight prevented these changes almost completely. 2) The lung of rats given ANTU appeared like liver in consistency, with intense hemorrhage and edema, and all the animals died within four hours. Hydrocortisone given prophylactically in a dose of 3 mgm per kilogram of body weight suppressed those changes and prolonged the survival period to 16 hours or more. 3) Many of the dogs subjected to the sequence of pneumonectomy, anoxia and intravenous infusion developed in typical pulmonary edema. Although improvements in respiratory and circulatory dynamics were noted in the group treated solely with IPPB/i O2, improvements in oxygen saturation, and blood flow in omental capillaries were better in the group treated with hydrocortisone in addition to IPPB/i O2. This was reflected in pathohistological findings and JORDAN II-IV changes still persisted in the control group (IPPB only) whereas in the group treated with hydrocortisone and IPPB only JORDAN C-II changes were noted, and water content of lungs returned to the value noted before edema developed.

News (Medical) associated with Hydrocortamate Hydrochloride

14 Jun 2022

·www.globenewswire.com

Covis Pharma Provides Update on FDA Public Hearing for Makena®

ZUG, Switzerland, June 14, 2022 (GLOBE NEWSWIRE) -- Covis Pharma GmbH, an affiliate of Group S.à r.l. (collectively, “Covis”), announced today that the U.S. Food & Drug Administration (FDA) anticipates holding a meeting of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) on October 17-19, 2022, to conduct a hearing about the future of Makena® (hydroxyprogesterone caproate injection). More information about the structure of the hearing can be found here. Prior to the hearing, FDA will publish a notice in the Federal Register that provides details on how to submit a request to FDA to participate in the hearing. FDA’s announcement of the anticipated hearing date is the latest development following FDA’s August 2021 order granting a hearing on its proposal to withdraw approval of Makena and its five generic versions. Covis requested that hearing in 2020, after FDA proposed to withdraw approval and issued a Notice of Opportunity for a Hearing (NOOH). FDA proposed to withdraw Makena’s approval following a 2019 Advisory Committee split vote (9-7) after a review of the PROLONG trial results, which did not confirm the benefit of 17-OHPC in a different population of women than those studied in the approval trial (Meis et al). Along with its five generic versions, Makena, also referred to as 17 α-hydroxyprogesterone caproate, 17-OHPC, 17-HPC, or 17P, is the only FDA-approved treatment to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. FDA’s final decision will be made following the October 2022 hearing. Covis continues to welcome the opportunity to discuss a data-driven path forward to address the conflicting efficacy results between two clinical studies on Makena, including the completed confirmatory study. “Covis is committed to working with the FDA to conduct additional research to explore and document the benefits of Makena. We are committed to further study to clarify the risk-benefit of this drug, given the inconsistent efficacy outcomes between the landmark Meis study and PROLONG, and the important role Makena plays in this high-risk and underserved patient population,” said Covis CEO Michael Porter. “This need for further study is underscored by the very fact that there are no approved alternatives available for high-risk patients – who for over a decade have been relying on this product and its generic versions to help carry their babies to term.” Covis has urged FDA to allow the company to do additional research to fully explore the efficacy of Makena for indicated patients and looks forward to presenting proposed study options at the October hearing. In this context, Covis is working diligently with experts to develop feasible and timely options that improve upon the previous sponsor’s proposal for additional studies. Specifically, Covis is exploring two alternative options: (1) conducting a prospective historical control study, consistent with FDA guidance, and/or (2) conducting a randomized clinical trial (RCT) relying on an analysis of retrospective datasets for the purpose of identifying relevant subgroups for study. Covis is currently conducting feasibility analyses and will follow the emerging data on the appropriate study option. The company proposes to undertake an appropriate study while ensuring that approved therapeutic options remain available. At this time, Makena remains approved and available, and the product label remains unchanged. About CovisCovis, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com. Media Contactpress@covispharma.com

19 Aug 2021

·www.biospace.com

Covis Pharma Announces FDA’s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients

ZUG, Switzerland, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Covis Group S.à r.l. (“Covis”) announced today that the U.S. Food and Drug Administration (FDA) has granted a public hearing to discuss Makena, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth in indicated patients. The hearing follows Covis’ October 2020 formal request for a public hearing in response to the FDA’s Notice of Opportunity for a Hearing (NOOH) regarding the Agency’s proposal to withdraw approval of Makena in all its forms. “We are grateful that the FDA responded to our request and has decided to grant a hearing to discuss Makena,” said Covis CEO Michael Porter. “Preterm birth remains an urgent public health issue in our country, particularly among minority groups. We believe that Makena is an important treatment option and we appreciate the opportunity for healthcare providers and patient populations at greatest risk to share their perspectives with the FDA as it considers the future of Makena.” Along with its generic equivalents, Makena, also referred to as 17 α-Hydroxyprogesterone Caproate, 17-OHPC, 17-HPC, or 17P, was approved in 2011 and is the only FDA-approved medication to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. Makena’s approval was based on a landmark clinical trial of U.S. women with a history of spontaneous preterm birth which demonstrated that Makena reduced the rate of preterm birth rates by one-third, compared to placebo treatment. FDA’s NOOH followed the results of a confirmatory study involving primarily non-U.S. patients and a divided Advisory Committee vote. At this time, Makena remains approved and available, and the product label remains unchanged. About Covis Covis, with global operations in Zug, Switzerland, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at . Media Contact info@covispharma.com

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100 Deals associated with Hydrocortamate Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
-	Hydrocortamate Hydrochloride	-	DB00769

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Indication	Country/Location	Organization	Date
Skin Diseases	US	Pfizer Laboratories (Pty) Ltd.	15 Oct 1956

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