Progesterone is under clinical development by IBSA Institut Biochimique and currently in Phase III for Female Infertility. According to GlobalData, Phase III drugs for Female Infertility have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Progesterone’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Progesterone overview
Progesterone (Prontogest / Lutogin / Lubion / Prolutex / Inprosub / Progedex / Pleyris) is major progestational steroid that is secreted primarily by the corpus luteum and the placenta. It is formulated as injectable solution and powder for solution for intramuscular or subcutaneous route of administration, capsules for oral route of administration. It is indicated in adults for luteal support as part of a program of technology assisted reproduction (tra) in infertile women, who can not use or tolerate preparations vaginal, and it is used in the preparation for gynecological and extraginecological surgery to be performed during pregnancy, threat of abortion, habitual abortion, threat of premature birth, hypermenorrhea, polymenorrhea, metrorrhagia, amenorrhea, hypomenorrhea, oligomenorrhea, premenstrual syndrome, prophylaxis of postpartum depression, as Progestin supplement in the luteinic phase during spontaneous or induced cycles, in case of hypofertility or primary or secondary ovarian failure.
Progesterone is under development for the treatment of women infertility. The drug candidate is administered through subcutaneous route.
Progesterone was also under development for the treatment of coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
IBSA Institut Biochimique overview
IBSA Institut Biochimique (IBSA) is a pharmaceutical company that manufactures and markets hormones, soft gel capsules and finished products. The company offers products in therapeutic areas of dermatology, endocrinology, rheumatology, pain and inflammation, human reproduction, osteoarticular, cardiometabolic, consumer health and urology. It uses technology for the purification process, soft capsules, to form hybrid cooperative complexes, topical patches orodispersible films (ODF) pre-filled syringes and others. IBSA also offers licensing out and licensing in services. The company provides manufacturing, regulatory expertise and direct marketing of proprietary products, and research in preclinical and clinical development. It markets its products in Australia, Bulgaria, Chile, Egypt, France, Indonesia, Israel, Malaysia, Oman, Portugal, Singapore, Switzerland, Germany, Italy, Poland, the UAE, the UK and the US. IBSA is headquartered in Lugano, Switzerland.
For a complete picture of Progesterone’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
