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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

PubMedJournal of the National Cancer Institute2026-09-10

Endocrine Biomarker Changes in a Randomised Low-Dose Tamoxifen Trial for Breast Cancer Prevention.

Nash Stephen S, Hammarström Mattias M, Thörngen John-Olof JO, Winqvist Ola O et al.

Tamoxifen reduces breast cancer incidence and recurrence, but uptake for primary prevention remains limited, largely because of concerns regarding adverse effects at the standard 20 mg dose. Understanding systemic endocrine effects of lower tamoxifen doses may help improve future prevention strategies. We analysed data from 1,055 healthy women enrolled in the randomised, double-blind, placebo-controlled KARISMA trial, assigned to placebo or tamoxifen 1, 2.5, 5, 10, or 20 mg daily for 6 months. Plasma concentrations of endocrine biomarkers and tamoxifen metabolites were measured at study end. Associations between randomised tamoxifen dose, circulating metabolite concentrations, and endocrine biomarker plasma concentration (estrogens, androgens, progestogens, cortisol, prolactin, and sex hormone-binding globulin (SHBG)), were evaluated. Tamoxifen dose was associated with measurable endocrine changes after six months, most consistently increased SHBG levels, with additional associations observed for cortisol and hydroxyprogesterone. SHBG demonstrated the clearest dose-response relationship, with increasing levels across tamoxifen dose groups and evidence of attenuated increase at intermediate doses. Large relative differences between placebo and 20 mg tamoxifen were additionally observed for estrone, estrone sulphate and estradiol. Unadjusted analyses of circulating endoxifen showed broadly similar endocrine patterns; however, these associations were substantially attenuated after adjustment for randomised tamoxifen dose. Circulating tamoxifen metabolites were strongly correlated with administered dose and with one another. Low-dose tamoxifen was associated with measurable endocrine changes, particularly in SHBG, cortisol, and hydroxyprogesterone. These findings show endocrine pharmacodynamic responses during low-dose tamoxifen therapy warrants further investigation as a potential component of future individualised prevention and adjuvant endocrine therapy strategies. ClinicalTrials.gov ID: NCT03346200.

PMID 42720596
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PubMedmBio2026-09-10

Sex and age differences in antibody responses to seasonal influenza vaccination are mediated by estrogenic upregulation of NF-κB and TNF signaling in B cells.

Park Han-Sol H-S, Yin Anna A, Zhou Weiqiang W, Wenstedt Eliane F E EFE et al.

Sex differences in the humoral immune responses to the seasonal quadrivalent influenza vaccine (QIV) in young adults (YA; 18-49 years old) or high-dose QIV in old adults (OA; 75+ years old) were analyzed to determine how age-related changes, including in steroids, impact sex differences in B cells. Among YAs, females had greater H3N2, but not H1N1, neutralizing antibody titers, and greater proportions of hemagglutinin (HA)+ CD19+ B cells and HA+ memory B cells than males through 28 days post-vaccination (DPV), that was not observed among OAs. Machine learning algorithms illustrated that baseline (0 DPV) steroids, including 17-hydroxyprogesterone, estrogens, and testosterone, as well as HA+ CD19+ B cells and HA+ antibody-secreting B cells (ASCs), were major predictors of seroconversion at 28 DPV, particularly in YA. Single-cell RNA sequencing demonstrated that CD19+ B cells from YA females had greater transcriptional activity at 7 DPV than YA males, with upregulation of genes with estrogen-response elements (EREs) along NF-κB-mediated TNF signaling pathways in B-cell subsets, which was mitigated in OA. Estradiol treatment of ASCs from YA females, but not males, increased the number and size of HA+ IgG+ cells and expression of ERE genes along the NF-κB-mediated TNF signaling pathway,that was inhibited by an estrogen receptor antagonist. Pharmacological inhibition of either NF-κB or TNF signaling blocked the ability of E2 to upregulate antibody secretion in cells from YA females. This study provides mechanistic insights into estrogen-mediated increases in influenza vaccine-induced antibody responses among reproductive-aged females and suggests a role for estrogen signaling in the reduction of sex differences in vaccine-induced immunity with old age. Sex differences in influenza vaccine-induced immune responses become less pronounced with old age, which we hypothesize could be related to changes in circulating gonadal steroids. Our study shows that after receipt of the seasonal influenza vaccine, young adult females, who have elevated estrogenic activity, have more B cells that recognize influenza hemagglutinin; their B cells have greater activity along estrogen signaling and inflammatory pathways, and mount stronger antibody responses than young adult males, with these sex differences being mitigated in old adults. We identify estrogen as a key driver of sex differences in influenza immunity by showing that ex vivo estradiol increases antibody production by B cells through the estrogen receptor and engagement with NF-κB. These findings help explain the biological basis for sex differences in vaccine immunity and suggest that the hormonal environment, not just chronological age, shapes how well a person responds to vaccination.

PMID 42720319
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PubMedIndian journal of clinical biochemistry : IJCB2026-09-09

Serum 17 Alpha-Hydroxyprogesterone Analysis- Performance Evaluation of Maglumi® X-8 Chemiluminescence Immunoassay.

Ahmed Sibtain S, Siddiqui Ayra A, Lakhani Shan S, Khan Samia S et al.

Congenital Adrenal Hyperplasia (CAH) is primarily caused by 21-hydroxylase deficiency, leading to abnormal adrenal hormone production. Accurate measurement of 17-hydroxyprogesterone (17-OHP) is critical for diagnosing and managing CAH. Traditionally, 17-OHP levels are assessed using ELISA, but methods like chemiluminescent immunoassays (CLIA) offer potential improvements in accuracy and efficiency. We evaluated the Maglumi® X-8 CLIA system for measuring 17-OHP levels and compared its performance with the established ELISA method. The study included serum samples from 39 patients, analyzed for accuracy, precision, linearity, and reportable range. The correlation between CLIA and ELISA results was assessed using regression analysis and Bland-Altman plots. The Maglumi® X-8 CLIA demonstrated acceptable precision, with low coefficients of variation (CVs) at both low and high 17-OHP concentrations. The assay showed strong correlation with the ELISA method (slope: 0.961, intercept: 1.712) and consistent accuracy across a broad reportable range (0.10 to 320 ng/mL). The CLIA system also proved to be faster and more automated, reducing the potential for human error and facilitates faster results for clinical decision making. The Maglumi® X-8 CLIA is a highly precise, accurate, and efficient method for measuring 17-OHP levels, making it a suitable alternative to ELISA in clinical laboratories. Its integration into routine workflows offers faster results and improved reliability.

PMID 42712792
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PubMedHuman reproduction open2026-09-08

Once-daily, late-night, modified-release hydrocortisone rapidly normalizes menstrual cyclicity in women with non-classic congenital adrenal hyperplasia.

Auer Matthias K MK, Tschaidse Lea L, Dervishi Orsela O, Kruse Pia P et al.

Does late-night, modified-release hydrocortisone (MR-HC) improve biochemical control and restore menstrual regularity in women with non-classic congenital adrenal hyperplasia (NCCAH)? Once-daily MR-HC substantially improved biochemical androgen control and rapidly restored menstrual cyclicity in women with NCCAH, including those with longstanding irregular cycles. While pregnancy rates in women with NCCAH are generally comparable to those of the general population, time to conception is often prolonged and assisted reproductive techniques are frequently required. Optimizing adrenal androgen suppression through the superior pharmacokinetic profile of MR-HC may shorten this interval and reduce the need for fertility interventions. So far, MR-HC has not been tested in NCCAH. Prospective observational cohort study conducted between September 2021 and November 2025 at a tertiary referral center and European Reference Network (Endo-ERN) hub for congenital adrenal hyperplasia. Thirty women with NCCAH were enrolled and followed for a median of 22.5 months (interquartile range [IQR] 8.25-36.75), with up to five study visits. Only women with at least 3 months of follow-up were included in the analysis. The cohort comprised 30 women with NCCAH. At initiation of MR-HC, 20 women transitioned from conventional glucocorticoid therapy, and 10 were treatment-naïve. Sixteen women had an active desire to conceive, while 15 presented with irregular menstrual cycles or secondary amenorrhea at baseline. Among 14 evaluable women, ovulatory function, defined as return of regular menstrual cycles or conception, was restored in 13 (92.6%) of women within 6 months of MR-HC initiation. One woman with concomitant hypothalamic hypogonadism remained amenorrhoeic and commenced hormone replacement therapy. Cycle normalization occurred at a median MR-HC dose of 10 mg (IQR 10-15 mg), with all but one woman receiving a single bedtime dose. Among 16 women seeking pregnancy, ten conceived within a median of 2.65 months (IQR 2.0-12.4) compared to 8 months (IRQ 1.0-24.0) in a historic cohort of NCCAH women before the approval of MR-HC (not significant). Among those seeking pregnancy, 10 women had been attempting to conceive unsuccessfully for a median of 28.5 months (IQR 12-46) before. Six women did not become pregnant during follow-up (13.5 months; IQR 6.25-23). The hydrocortisone equivalent dose (HCeq) at the time of conception was significantly lower under MR-HC (10.0 mg (IQR 10-12.5) vs. 16.9 mg (IQR 15-25), P = 0.02) in the historic cohort. Transition to MR-HC led to marked reductions in early-morning salivary 17-hydroxyprogesterone and serum testosterone, independent of prior glucocorticoid (GC) exposure. Metabolic effects were minimal: body weight decreased slightly, glycated hemoglobin (HbA1c) rose transiently, predominantly in treatment-naïve women, before returning to baseline. Blood pressure, fasting glucose, and lipid profiles remained stable. While the rapid normalization of, in part, long-standing menstrual irregularities was striking, the absence of a control group does not allow causal inferences, and the single-center design within a specialized tertiary setting may limit generalizability. A single nightly dose of MR-HC appears sufficient to achieve hormonal control and subsequent menstrual-cycle restoration in most women with NCCAH and may improve time to conception. These findings support MR-HC as a promising therapeutic option in the management of NCCAH. This work was supported by the Deutsche Forschungsgemeinschaft (Heisenberg Professorship 325768017, project 314061271 TRR205 to NR and FBCRC-1665 -515637292 to NR and UK). LT was supported by the LMU Munich funding scheme (FöFoLe) and by the IFCAH (International Fund Congenital Adrenal Hyperplasia) grant 2023. HN was supported by the Clinician Scientist Program RISE, supported by the Eva Luise und Horst Köhler Stiftung & Else Kröner-Fresenius-Stiftung (2019_KollegSE.03 to HN). N.R. was Principal Investigator and consulted for Neurocrine Biosciences and Diurnal Ltd. L.T., M.K. A. und H.F.N. were Sub-Investigators for Neurocrine Biosciences and Diurnal Ltd. N/A.

PMID 42707769
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PubMedFood research international (Ottawa, Ont.)2026-09-07

Depth-dependent microbial succession and interspecies hydrogen transfer drive pit mud maturation in Chinese strong-flavor baijiu fermentation.

Xu Shanshan S, Li Jingwen J, Wang Fei F, Bian Huixi H et al.

Microbial communities in fermentation pit mud play a key role in determining the quality of Chinese strong-flavor baijiu (CSFB). However, the ecological processes underlying pit mud maturation across spatial and temporal scales remain unclear. In this study, amplicon sequencing and metagenomic analyses were employed to investigate the taxonomic succession, community assembly, and metabolic functions of bacterial and archaeal communities during the transition from fresh pit mud (FPM) to new pit mud (NPM) and old pit mud (OPM). A pronounced depth-dependent succession pattern was observed, with 4 cm representing a critical ecological boundary separating distinct community structures and maturation trajectories. During surface-layer maturation, community assembly shifted from stochastic to deterministic processes, accompanied by homogeneous selection and increasing network complexity. In contrast, stochastic processes remained dominant throughout deep-layer maturation. Metagenomic analyses revealed a functional transition from lactate and acetate production, primarily associated with Lactobacillus in FPM and NPM, to butyrate and caproate production associated with Clostridium and Caproiciproducens in OPM. This functional transition was accompanied by enhanced amino acid metabolism, which was associated with the enrichment of Proteiniphilum and Aminobacterium. Notably, methanogen-mediated interspecies hydrogen transfer (IHT) emerged as a key ecological feature during pit mud maturation. In OPM, IHT networks primarily involving Methanobacterium and Methanosarcina linked methanogenesis with reverse β-oxidation through diverse hydrogen-transfer pathways, reinforcing metabolic interactions underlying caproate production. These findings provide new insights into the ecological mechanisms underlying pit mud maturation and offer a theoretical basis for the directed cultivation of high-quality pit mud in CSFB production.

PMID 42705727
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PubMedEndocrinology, diabetes & metabolism2026-09-02

Gonadotropin Suppression During Mini-Puberty as an Early Biomarker of Classic 21-Hydroxylase Deficiency.

Iemura Ryosei R, Suzuki Yuri Y, Gau Maki M, Orimoto Ryuta R et al.

Newborn screening (NBS) for congenital adrenal hyperplasia caused by 21-hydroxylase deficiency (21OHD) relies on elevated 17-hydroxyprogesterone (17OHP) levels but is limited by a high false-positive rate and difficulty in distinguishing classic from non-classic forms. To evaluate whether the suppression of serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) during mini-puberty can serve as an early biomarker of classic 21OHD. We conducted a retrospective cohort study of 37 infants evaluated for suspected 21OHD between 2013 and 2025. Subjects were classified as classic (C), non-classic (NC), or false-positive (FP) based on biochemical and genetic confirmation. Neonatal serum LH and FSH levels were compared among groups, and receiver operating characteristic (ROC) analyses were performed. LH and FSH levels were significantly suppressed in classic 21OHD compared with NC and FP cases (p < 0.001). Gonadotropin concentrations demonstrated a stepwise pattern (C

PMID 42682192
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