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hydroxyprogesterone caproate (Makena SQ / 17P / Makena)

✓ Approved

Lumara Health · PGR

什么是 hydroxyprogesterone caproate？

hydroxyprogesterone caproate 是一种治疗药物，由Lumara Health研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Subcutaneous Injection。

药物档案

商品名Makena SQ, 17P, Makena
公司Lumara Health
分子靶点PGR
给药途径Injectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Lumara Health

作用机制

分子靶点

hydroxyprogesterone caproate 作用于 1 个分子靶点：

PGRprogesterone receptor (NR3C3, PR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

hydroxyprogesterone caproate 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Pregnancy, puerperium and perinatal conditionsPremature labour✓ Approved

相关研究文献

PubMedClinical endocrinology2026-08-04

Clinical, Biochemical, and Molecular Spectrum of Pseudohypoaldosteronism Type 1B in Indian Children: A Multicentric Case Series.

Dhananjaya Melkunte Shanthaiah MS, Jakkadi Leenatha L, Lalitha Parvathy P, Rao L Prasadh LP et al.

Pseudohypoaldosteronism type 1 (PHA1) is a rare hereditary disorder characterised by aldosterone resistance leading to salt wasting, hyperkalaemia, and metabolic acidosis. Two forms are recognised: a milder renal form (PHA1A) due to NR3C2 mutations and a severe systemic form (PHA1B) caused by biallelic mutations in epithelial sodium channel (ENaC) subunit genes. Data on Indian patients are scarce. This study describes the clinical, biochemical, and molecular characteristics and treatment outcomes of children with PHA1 from South India. This multicentric retrospective series included nine children diagnosed with PHA1 across six tertiary care centres between 2022 and 2025. Clinical and biochemical data were extracted from hospital records. Plasma renin, aldosterone, cortisol, and 17-hydroxyprogesterone were measured at presentation. Genetic testing was performed using clinical exome sequencing, and variants were classified according to American College of Medical Genetics and Genomics (ACMG) guidelines. All nine patients had the systemic form (PHA1B). The median age at presentation was 14 days (interquartile range 5.5-42.5), and parental consanguinity was present in seven (78%). All presented with hyponatraemia and hyperkalaemia (median serum sodium 124 mEq/L; potassium 8.0 mEq/L). Eight (pathogenic/likely-pathogenic: 4, supporting: 4) homozygous variants were identified in SCNN1A (n = 2), SCNN1B (n = 3), and SCNN1G (n = 3); all were novel. Six patients (67%) died, mainly due to sepsis (n = 2) or treatment discontinuation (n = 4), while three remain stable on oral sodium supplementation. This first multicentric South Indian series highlights exclusive reporting of PHA1B, high early mortality, and major treatment challenges. Eight novel ENaC variants expand the genetic spectrum of PHA1B in India.

PMID 42549990
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PubMedNigerian medical journal : journal of the Nigeria Medical Association2026-08-03

Beckwith-Wiedemann Syndrome Presenting with Transient Features of Congenital Adrenal Hyperplasia in a Nigerian Neonate.

Oyenusi Elizabeth Eberechi EE, Elemo Olaide Oludolapo OO, Kene-Udemezue Blessing Ebele BE, Oleolo-Ayodeji Khadijah Omobusola KO et al.

Presentation of Beckwith-Wiedemann syndrome (BWS) is widely variable. Congenital adrenal hyperplasia (CAH) is the leading cause of atypical genitalia in the female newborn. Beckwith-Wiedemann syndrome was previously not recognized as a possible cause of a false diagnosis of CAH. A late preterm (gestational age of 36 weeks) female presented at the 3rd hour of life with an anterior abdominal wall defect and swelling. Examination revealed coarse facial features, macroglossia, omphalocele major, prominent labia majora with hyperpigmented and enlarged clitoris. Weight was >97th percentile for age and sex, with length and occipitofrontal circumference at 95th and 50th percentiles, respectively. Initial blood investigations revealed hypoglycaemia, hyponatraemia, hypocortisolaemia, elevated testosterone and 17-hydroxyprogesterone with female internal genitalia suggesting CAH. She was commenced on hydrocortisone. Omphalocele was managed conservatively. Abdominal ultrasound scan showed no enlargement of the adrenal glands or tumours. Genetic analysis showed hypomethylation at KCNQ1OT1: TSS-DMR (IC2) within 11p15.5, confirming a diagnosis of BWS. Clitoromegaly resolved spontaneously at six months of life without any surgical intervention, with normal pigmentation of the external genitalia. Steroids were tapered off, and repeat adrenal metabolites are normal. BWS may present with transient features suggestive of CAH.

PMID 42544153
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PubMedWater research2026-07-31

A critical review of biochar-enabled chain elongation for n-caproate production: From empirical addition to rational design.

Zhang Yu-Tong YT, Chen Chuan C, Sun Zhong-Fang ZF, Tan Jing-Yan JY et al.

Microbial chain elongation (CE) offers a vital pathway to upcycle waste-derived short-chain carboxylates into medium-chain carboxylates, such as n-caproate (C6). However, its translation to robust continuous operation remains constrained by two coupled bottlenecks: electron diversion to competing sinks and product inhibition governed by undissociated caproic acid (HCap). While biochar is widely reported to enhance CE performance, mechanistic attribution often relies on non-diagnostic indicators, such as higher titers, faster start-up, or community shifts, derived mainly from short-term batch tests. This review critically synthesizes the fundamental bottlenecks of n-caproate CE and links biochar feedstock legacy, pyrolysis conditions, and particle architecture to key interfacial functions. These functions include biomass retention, redox mediation, conductivity-related effects, micro-pH buffering, and community stabilization. Since these functions can co-occur and mimic one another at the reactor scale, we propose a CE-specific evidence-strength framework to map mechanistic claims to minimum evidence requirements and major confounders, thereby distinguishing genuine material functions from adsorption, retention, buffering, and reporting artifacts. We then examine scale-up barriers, including material heterogeneity, rheological and mass-transfer penalties, biochar aging/passivation, attrition, washout, and recovery difficulty. Finally, we outline a roadmap toward CE-grade biochar specifications, standardized reporting metrics, and reactor-separation co-design. This review aims to move biochar-enabled n-caproate CE from empirical additive use toward predictable and evidence-based design for continuous waste-to-chemicals biomanufacturing.

PMID 42531876
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PubMedArchives of endocrinology and metabolism2026-07-31

Timing of 17-hydroxyprogesterone measurement during the standard-dose Synacthen test in pediatric patients evaluated for non-classical congenital adrenal hyperplasia due to 21-hydroxylase deficiency.

Çiftci Nurdan N, Çamtosun Emine E, Dündar İsmail İ, Ünal Edip E et al.

We aimed to evaluate the diagnostic utility of the 30-minute 17-hydroxyprogesterone (17-OHP) measurement during the standard-dose Synacthen test. This retrospective study analyzed the medical records of patients aged 0-18 years who underwent Synacthen testing for suspected non-classical congenital adrenal hyperplasia due to 21-hydroxylase deficiency between 2000 and 2024. Among 150 patients included, the median age was 13 years (range 5.5-18), and 85.3% were female. Twenty-nine patients exhibited a peak stimulated 17-OHP level ≥ 10 ng/mL. In three of these patients, the 30-minute 17-OHP level was within normal limits, whereas all had diagnostic 17-OHP levels at 60 minutes. No patients exhibited a diagnostic 17-OHP level at 30 minutes with a non-diagnostic value at 60 minutes. Using a basal 17-OHP cut-off value of 3.78 ng/mL, sensitivity and specificity were 89.7% and 94.2%, respectively. The V281L variant was the most frequently identified pathogenic variant. The 60-minute 17-OHP measurement demonstrated greater diagnostic sensitivity than the 30-minute measurement in this cohort and may provide adequate diagnostic information in pediatric patients evaluated for non-classical congenital adrenal hyperplasia, as no additional cases were identified exclusively at the 30-minute time point.

PMID 42536762
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PubMedEndocrine connections2026-07-29

11-deoxycortisol, other hormones and pituitary function characteristics in the diagnosis of adrenal insufficiency in the overnight oral metyrapone test.

Krawzow Alexander A, Peitzsch Mirko M, Bastian Manuela M, Postrach Till T et al.

The oral metyrapone test is utilized to assess pituitary adrenal axis function. We asked whether 17-hydroxyprogesterone, androstenedione or corticotropin are similarly as useful as 11-deoxycortisol to detect adrenal insufficiency. Of the SHIP-PAGE study participants, 190 patients underwent an oral metyrapone test. The diagnosis of adrenal insufficiency included information from the clinical course, concentrations of adrenal steroids and ACTH before or after metyrapone as well as results of other pituitary function tests. Of the 190 patients, 67 had adrenal insufficiency and 123 had not. ROC analysis showed the highest sensitivity (83 %), specificity (>90 %) and area under the curve of 0.9 for 11-deoxycortisol at a cut-off of 197 nmol/l. Surges in 11-deoxycortisol were related to those of 17-hydroxyprogesterone, androstenedione, and corticotropin that displayed lower sensitivities, specificities and areas under the curve with cut-off values of 5.55 nmol/l, 8.11 nmol/l and 89.60 pg/ml, respectively. Presence of gonadal dysfunction had a high sensitivity of 61 % and prolactin deficiency a high specificity (96 %) for prediction of adrenal insufficiency as had a combined dysfunction of the gonadal, growth hormone, and thyroid axes (97 %). In conclusion, 11-deoxycortisol is an already established parameter with a good performance in the oral metyrapone test which was not outperformed by 17-hydroxyprogesterone, androstenedione, or corticotropin. However, there maybe a substantial bias to this result. Therefore, determination of pituitary-end-organ axes functions is likewise helpful to provide probability information in the assessment of adrenal insufficiency which remains a diagnosis based on clinical information and endocrine function tests. The oral metyrapone test is very useful for the characterization of adrenal function. If available, analysis of 11-deoxycortisol is better than measurements of other adrenal steroid hormones or corticotropin. However, there may be a bias from previous studies on the metyrapone test. Therefore, analysis of corticotropin, androstenedione, and 17-hydroxyprogesterone concentrations at baseline and the day after metyrapone administration are also very helpul for evaluation of adrenal function when the results from other pituitary function tests are included in the diagnostic process.

PMID 42525124
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PubMedChildren (Basel, Switzerland)2026-07-28

Progesterone Exposure in Pregnancy, Obstetric Stabilization, and Developmental Outcomes: A Focused Review of Direct and Indirect Pathways.

Dugalic Stefan S, Dugalic Miroslava Gojnic MG, Milincic Milos M, Ivanovic Katarina K

Progesterone is an endogenous pregnancy hormone widely used in reproductive medicine and obstetrics. Its developmental relevance should be interpreted by distinguishing direct molecular plausibility from indirect obstetric effects, including stabilization of the maternal-decidual-placental maternal-decidual-placental environment, cervical stability, and prolongation of gestation. A focused qualitative narrative review was performed using targeted literature searches and thematic synthesis. This approach was chosen because the available evidence is heterogeneous with respect to indication, formulation, route, dose, timing, comparator group, and offspring follow-up, making quantitative synthesis inappropriate for the present objective. Direct progesterone-related pathways include receptor-mediated signaling, neuroactive metabolites, and biologically plausible epigenetic regulation; however, human evidence for persistent therapy-induced molecular programming remains limited. Indirect pathways are better supported and include decidualization, immune tolerance, placental stabilization, cervical integrity, uterine quiescence, and prevention of prematurity in selected pregnancies. Clinical evidence should be interpreted separately for placebo-controlled trials, untreated pathological cohorts, and observational follow-up studies because underlying maternal conditions may themselves influence offspring outcomes. Potential risk signals also require formulation-specific interpretation, particularly for synthetic progestogens and 17-alpha hydroxyprogesterone caproate, for which long-term observational data and regulatory reassessments have raised concerns regarding efficacy and possible offspring safety signals. Inadvertent exposure to contraceptive progestins during unrecognized pregnancy, including progestin-only preparations and levonorgestrel-releasing intrauterine systems, should be considered separately from therapeutic obstetric progesterone use. Available evidence has not shown a consistent early adverse signal for natural progesterone when used for recognized indications, although long-term offspring data remain limited and cannot be generalized to synthetic progestogens or 17-alpha hydroxyprogesterone caproate. Progesterone-related therapies should be considered indication-specific and formulation-specific rather than interchangeable. Current evidence supports a cautious and comparator-aware interpretation: natural progesterone appears acceptable for recognized clinical indications based on available short-term and early childhood data, but evidence beyond early childhood remains insufficient for broad safety generalizations.

PMID 42509978
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