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hydroxyprogesterone caproate (Makena SQ / 17P / Makena)

✓ Approved

Lumara Health · PGR

What is hydroxyprogesterone caproate?

hydroxyprogesterone caproate is a therapeutic agent developed by Lumara Health. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or subcutaneous injection.

Drug Profile

Brand NamesMakena SQ, 17P, Makena
CompanyLumara Health
Molecular TargetPGR
RouteInjectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Lumara Health

Mechanism of Action

Molecular Targets

hydroxyprogesterone caproate acts on 1 molecular target:

PGRprogesterone receptor (NR3C3, PR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

hydroxyprogesterone caproate is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Pregnancy, puerperium and perinatal conditionsPremature labour✓ Approved

Related Research Articles

PubMedBioresource technology2026-07-17

N-(3-oxohexanoyl)-homoserine lactone-assisted enrichment reshapes functional microbial consortia for chain elongation in electrofermentation.

Qiang Haifeng H, Jing Yimin Y, Xu Xianbao X, Heo Seongbong S et al.

The functional microbial consortia supporting chain elongation determine medium-chain carboxylate recovery from organic wastes, but how signal-molecule-assisted enrichment shapes chain-elongating bacteria (CEB), electroactive bacteria (EAB), and competing guilds in electrofermentation remains unclear. Here, three N-acyl-homoserine lactones: N-butyryl-homoserine lactone (C4-HSL), N-octanoyl-homoserine lactone (C8-HSL), and N-(3-oxohexanoyl)-homoserine lactone (3OC6-HSL), were supplied during microbial enrichment, and the subsequent electrofermentation was conducted fed with sludge fermentation broth. Compared with the Control (without signaling molecules), 3OC6-HSL had the strongest response, increasing caproate production by 94.0%, compared with 16.9% and 27.3% for C4-HSL and C8-HSL, respectively. It also increased the apparent caproate electron transfer efficiency by 20.7 percentage points, increased the abundance of CEB (44.9% vs. 33.2%) and EAB (14.3% vs. 6.6%), and reduced the abundance of homoacetogens (12.1% vs. 33.7%). Co-occurrence network analysis revealed more modular and compact inferred associations, with 25.0% more modules and a 34.7-49.3% shorter average path length. Metagenomic analysis revealed enhanced reverse β-oxidation, QS, chemotaxis, and flagellar assembly potentials, and the expression levels of acetyl-CoA acyltransferase (ACAT/fadA) and acyl-CoA dehydrogenase (ACADS/ACADM) increased by 162.1% and 96.6%, respectively. Clostridium kluyveri dominated the ACAT contribution (85.9%). Overall, enrichment-phase 3OC6-HSL supplementation was associated with a caproate-oriented microbial consortium and improved caproate recovery without continuous signal dosing.

PMID 42462831
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PubMedAlzheimer's research & therapy2026-07-16

Steroid hormones in Alzheimer's disease: a molecular analysis of blood and cerebrospinal fluid.

Muk Tik T, Wretlind Asger A, Hooshmand Kourosh K, Clos-Garcia Marc M et al.

Alzheimer's disease (AD) disproportionately affects women, yet existing studies have been limited to single biofluids, individual hormones, or single dementia subtypes, leaving sex-stratified profiles across the cognitive impairment spectrum poorly defined. Here we address this gap by simultaneously quantifying nine steroid hormones spanning glucocorticoid (cortisol, 11-deoxycortisol), mineralocorticoid (aldosterone), progestogen (progesterone, 17-hydroxyprogesterone), androgen (testosterone, dihydrotestosterone), and estrogen (estradiol, estrone) pathways in paired CSF and plasma across five cognitive categories: no cognitive impairment, mild cognitive impairment (MCI) with AD pathology, MCI without AD pathology, AD dementia, and vascular dementia. Steroid hormones were quantified by liquid chromatography-tandem mass spectrometry in paired cerebrospinal fluid (CSF) and plasma samples drawn from the same individuals from a cross-sectional study including 204 participants across five cognitive categories at the Danish Dementia Research Centre. Gender-stratified generalized linear models adjusted for age were applied. Cortisol findings were validated externally using the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort (n = 426). Female participants with AD exhibited elevated CSF cortisol (fold change [FC] = 1.13; P = .04) and CSF 11-deoxycortisol (FC = 1.01; P = .03), alongside reduced plasma progesterone (FC = 0.90; P = .04). Male participants with AD showed elevated plasma aldosterone (FC = 1.19; P = 2.81e-03; q = 0.02). CSF cortisol correlated with amyloid-β42 and phosphorylated tau in female participants. ADNI validation confirmed elevated plasma cortisol in AD, with a larger effect in female participants. Gender-dependent steroid hormone dysregulation in dementia highlights cortisol and aldosterone as potentially modifiable targets warranting further investigation.

PMID 42458616
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PubMedObstetrics & gynecology science2026-07-16

Optimal androgen concentration cut-off values for identifying abnormal insulin sensitivity in Korean women with polycystic ovary syndrome.

Lee Seula S, An Hyeonjun H, Oh Soojin S, Chun Sungwook S

This study evaluated the relationship between serum androgen concentrations and validated insulin sensitivity indices in Korean women with polycystic ovary syndrome (PCOS) and established optimal androgen thresholds for identifying abnormal insulin sensitivity. A total of 180 Korean females aged 18-35 years with newly diagnosed PCOS were enrolled. Fasting-state insulin sensitivity assessment indices (ISAIs) were calculated, and participants with abnormal levels according to at least one established ISAI criterion were classified as having abnormal insulin sensitivity. Spearman's correlation analysis assessed relationships between insulin sensitivity parameters and four androgens: total testosterone (TT), free testosterone (FT), dehydroepiandrosterone sulfate (DHEA-S), and 17α-hydroxyprogesterone (17-OHP). Receiver operating characteristic (ROC) curve analysis was used to define the most accurate androgen cutoff values for predicting abnormal insulin sensitivity. Among the four androgens tested, TT, FT, and DHEA-S showed significant associations with most insulin resistance (IR) parameters, whereas 17-OHP showed no significant correlation. In the ROC curve analysis, only FT achieved moderately accurate predictive performance (area under the curve [AUC], 0.759), while TT, DHEA-S, and 17-OHP showed AUC values indicating less accurate predictions. The optimal FT cutoff to detect abnormal insulin sensitivity was 1.325 pg/mL (sensitivity, 77.8%; specificity, 64.0%). FT showed the strongest association with parameters related to insulin sensitivity and could serve as a complementary opportunistic indicator of IR in PCOS. Women with PCOS who had serum FT levels ≥1.325 pg/mL were identified as having abnormal insulin sensitivity.

PMID 42460482
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PubMedJournal of endocrinological investigation2026-07-13

Bone age advancement is associated with testicular adrenal rest tumors in boys with congenital adrenal hyperplasia.

Gürbüz Emre E, Kocaay Pınar P, Cetin Sirmen Kızılcan SK, Tepe Derya D et al.

Testicular adrenal rest tumors (TARTs) are benign, hormonally responsive testicular lesions in male patients with congenital adrenal hyperplasia (CAH). TARTs represent a leading contributor to gonadal dysfunction and infertility in this population. This study aimed to investigate the clinical and genetic characteristics of TARTs and to identify clinical indicators that may facilitate their early detection. A retrospective cohort study included 38 male patients with biochemically and molecularly confirmed CAH who were followed at our pediatric endocrinology clinic between January 2019 and January 2025. Demographic characteristics, underlying enzymatic defects, CYP21A2 and CYP11B1 genotype, clinical phenotype, hormonal profiles-including adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) concentrations-pubertal status, skeletal maturation as assessed by bone age, and scrotal ultrasonographic findings were systematically retrieved from medical records and analyzed. TARTs were identified in 14 of 38 patients, corresponding to a prevalence of 36.8%. Of the affected individuals, 12 (85.7%) harbored 21-hydroxylase deficiency and 2 (14.3%) had 11β-hydroxylase deficiency. No statistically significant differences were observed in ACTH or 17-OHP levels between patients with and without TART (p = 0.75 and p = 0.36, respectively). TARTs were significantly more prevalent among patients with the salt-wasting phenotype relative to other clinical forms (p = 0.002) and among pubertal compared with prepubertal patients (p = 0.016). Skeletal maturation, as reflected by bone age advancement, was significantly more pronounced in the TART-positive group (p = 0.012). Multivariable logistic regression analysis identified bone age advancement (OR = 1.76; 95% CI: 1.10-2.83; p = 0.019) and pubertal status (OR = 12.5; 95% CI: 1.7-91.6; p = 0.013) as factors independently associated with the presence of TART. Bone age advancement was independently associated with the presence of TART and may represent a clinically useful marker associated with TART in male patients with CAH. These findings suggest that bone age assessment may complement isolated hormonal measurements and may help identify patients who could benefit from closer ultrasonographic surveillance. Early detection and timely therapeutic intervention remain important for preserving gonadal function and future fertility.

PMID 42440236
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PubMedBioresource technology2026-07-10

Electro-driven valorization of waste activated sludge into caprylate (C8) via syngas-ethanol synergy.

Zhang Yan Y, Yu Delin D, Xu Xianbao X, Liu Zhihong Z et al.

Microbial chain elongation (CE) is a promising route for recovering value-added medium-chain carboxylic acids (MCCAs) from waste streams. Yet, compared with caproate (C6), caprylate (C8) biosynthesis remains challenging due to weak electron donor availability and insufficient understanding of C8-forming microbial assembly. This study examined ethanol-syngas synergy for caprylate upgrading of sludge fermentation broth in microbial electrosynthesis (MES). The two-stage syngas-ethanol reactor achieved the highest caprylate production of 4388 mg COD/L with 69.20 % selectivity, 1.40-51.65 times higher than other reactors. Ethanol supplementation enhanced syngas utilization, while syngas availability in turn promoted ethanol-driven CE, synergistically strengthening carbon flux toward caprylate. Microbial community analysis revealed a functional interaction network composed of homoacetogens, electroactive bacteria, hydrolytic/fermentative bacteria, and chain-elongating bacteria, which drove caprylate synthesis by channeling carbon and electrons derived from syngas and complex organics into the CE process. The two-stage syngas-ethanol reactor exhibited enhanced electron storage capacity and reduced charge transfer resistance, which accounted for its superior electron efficiency (53.69 %). Life cycle assessment and techno-economic analysis indicated that this strategy effectively reduced carbon emissions by 33 %, while also lowering operating costs by approximately 50 % due to reduced reliance on ethanol. This study offers a novel strategy integrating wastewater treatment with high-value chemical production, contributing to the advancement of carbon neutrality goals.

PMID 42425461
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PubMedEuropean journal of endocrinology2026-07-07

Using machine learning to discriminate non-classical 21-hydroxylase deficiency from polycystic ovary syndrome: an external validation study.

Lecot-Connan Tatiana T, Bachelot Guillaume G, Donadille Bruno B, Sayed Camille C et al.

Nonclassical 21-hydroxylase deficiency (NC21OHD) is a rare autosomal recessive disorder that is frequently misdiagnosed as polycystic ovary syndrome (PCOS) because of their overlapping clinical and biochemical presentations. The conventional diagnostic method, the cosyntropin stimulation test, is invasive, time consuming, and difficult to implement in routine clinical practice. To overcome these limitations, we previously developed a proof-of-concept machine learning model integrating basal serum steroid profiling by liquid chromatography with tandem mass spectrometry (LC-MS/MS) to identify NC21OHD without the need for dynamic stimulation testing. The present study aimed to validate and refine this model in a larger, multicentric cohort to evaluate its diagnostic performance in distinguishing NC21OHD from PCOS based on baseline steroid signatures. This tricentric study included 447 women: 263 with PCOS and 59 with NC21OHD in the training set (Pitié-Salpêtrière Hospital, Paris), and 104 PCOS and 21 NC21OHD in 2 independent validation cohorts (Saint-Antoine Hospital, Paris; Bordeaux University Hospital). Twenty serum steroids were quantified by LC-MS/MS and analyzed using orthogonal partial least squares discriminant analysis. Model robustness was assessed by internal cross-validation and external validation. 20-steroid model achieved complete separation between NC21OHD and PCOS in both external validation cohorts (accuracy = 100%). The most discriminant metabolites were 21-deoxycortisone, 21-deoxycortisol, and 17-hydroxyprogesterone. Simplified 3- and 6-steroid models demonstrated reduced sensitivity (∼90%) and specificity (∼97%). Machine learning combined with basal LC-MS/MS steroid profiling enables accurate identification of NC21OHD without dynamic stimulation. This approach could simplify diagnosis, improve patient comfort, and support large-scale screening of hyperandrogenic women.

PMID 42411601
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