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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 technology2026-05-21

Concentration-dependent variation in carbon allocation and microbial assembly in chain elongation microbiota: Comparative effects of acetate, ethanol, and lactate.

Song Ya-Ning YN, Chai Li-Juan LJ, Ao Ling L, Mei Jun-Lan JL et al.

This study evaluated the effects of acetate, ethanol, and lactate on anaerobic chain elongation (CE) using pit mud microbiota as a model inoculum. Substrate-normalized product carbon allocation analysis showed high acetate primarily yielded butyrate (31%). Ethanol concentrations of 15.8-31.6 g/L optimized caproate selectivity. High lactate (30 g/L) coincided with a shift in product distribution from caproate to odd-chain propionate (31%) and valerate (19%). Microbial succession and influencing factors were elucidated via linear mixed-effects models and Mantel tests. Acetate appeared to function as a basal substrate with relatively weak selective pressure. At 15.8-31.6 g/L ethanol concentrations, CE-related functional genera (e.g., Clostridium, Rummeliibacillus, and Caproicibacterium) were enriched, promoting efficient caproate synthesis. Conversely, higher ethanol levels (63.1 g/L) promoted Lactobacillus while suppressing CE functional genera via acidification and toxicity. High lactate concentrations (30 g/L) enriched Haloimpatiens, which was associated with odd-chain fatty acid pathways that produced propionate and valerate. Network topology analysis revealed that carbon sources differentially influenced microbial interaction networks. High acetate simplified network connectivity. Ethanol induced nonlinear effects: at 15.8 and 47.3 g/L, it fostered robust and highly connected networks that balanced competition and cooperation, while the 63.1 g/L concentration led to network sparsification and stability decay. In contrast, lactate concentration positively correlated with network complexity and stability. These findings provide a theoretical basis for managing carbon flux and community stability in anaerobic fermentation.

PMID 42162931
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PubMedJournal of animal science2026-05-21

Low methane phenotype of feedlot steers changes throughout production and depends on diet.

Williams Melissa S MS, Terry Stephanie A SA, Beauchemin Karen A KA

A better understanding of the variability in methane (CH4; g/day) emissions from beef cattle throughout production is necessary to implement mitigation programs. One hundred Angus crossbred steers were fed diets including either barley silage (BS) or corn silage (CS) throughout a backgrounding (BG) and finishing (FN) phase feedlot study. The objectives were to characterize the variability in methane yield (CH4Y; g/kg dry matter intake) among and within steers during BG and FN phases of production, assess whether the variability in CH4Y differs by silage type, examine the stability of CH4Y ranking (Low, Intermediate, or High) of steers within and across phases, and evaluate relationships between range of CH4Y, CH4 production, and feeding behavior. Cattle were fed a BG diet (70% silage and 22-26% barley grain on a DM basis) for 121 d followed by a FN diet (15% silage and 77-78% barley grain on a DM basis) for 158 d, with each phase comprised of two measurement periods. Steers were assigned to one of the silage sources for the entirety of the experiment with n = 50 each). Enteric CH4 was measured using GreenFeed emissions monitoring systems (C-Lock Inc., USA) for 2 weeks/period in BG and 2-3 weeks/period in FN. Steers were ranked based on their CH4Y (MYR) in each period and phase and categorized as Low (<0.5 SD from the mean), Intermediate (within ±0.5 SD of the mean), or High (>0.5 SD of the mean) emitters. Statistical analysis was performed within a period or phase using PROC GLIMMIX of SAS as a mixed model with fixed effects of MYR, silage, MYR×silage, and period or phase. Steer was the experimental unit, and the random effect accounted for individual variability. Rankings of individuals were compared across periods and phases to determine whether rankings changed over time. The CH4Y of steers ranked Low in period 1 were not different from Intermediate steers in period 2 of BG, with both being lower than High steers (P < 0.01). Similarly, steers ranked as Low in BG overall were not different from those ranked as Intermediate in FN for CH4Y (P < 0.01). During FN, Low and Intermediate steers differed in period 2, whether using period 1 or 2 ranking (P < 0.001). During BG, Low and Intermediate steers had a lower (P < 0.01) proportion of caproate in rumen fluid than High steers, and cattle fed BS had increased (P ≤ 0.01) propionate and valerate and decreased (P ≤ 0.01) acetate and NH3-N. During FN, Low steers had lower (P = 0.03) acetate and higher (P ≤ 0.04) propionate and isobutyrate proportions than High steers. Steers were more likely to change MYR during BG (56%) and from BG to FN (42%), compared to during FN (20%). During BG, 14% of BS and 71% of CS steers ranked as Low in period 1 changed rank in period 2. When steers were ranked as Low during BG, 43% (BS) and 57% (CS) had a different MYR in FN. Pearson correlation coefficients revealed a moderate to strong positive relationship between the CH4Y range and CH4 and CH4Y during FN for both silage sources (P < 0.05). For CS steers, feed intake decreased as the CH4Y range increased (P < 0.001; r = -0.61). In conclusion, the variability in CH4Y was present throughout BG and FN, and MYR was most likely to change within BG and across phases. Therefore, these results suggest that selecting steers for their MYR based on a short-term measurement may not reflect lifetime MYR within and across phases and diets.

PMID 42161349
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PubMedEuropean journal of endocrinology2026-05-20

Real-World Outcomes with Modified-Release Hydrocortisone in Classic Congenital Adrenal Hyperplasia.

Auer Matthias K MK, Bayer Kathrin K, Nowotny Hanna F HF, Tschaidse Lea L et al.

To evaluate outcomes after switching from conventional glucocorticoids to modified-release hydrocortisone (MR-HC; Efmody®) in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency under real-life conditions. Prospective, observational cohort study at a tertiary endocrine center. Sixty-two adults with classic CAH (25 male; 42 salt-wasting) were switched to MR-HC and followed up for at least 12 months and up to four visits or until termination of treatment (median 23.5 months; visit four not yet completed in 6/62). Outcomes included hormonal control, metabolic parameters and menstrual patterns. At baseline, 42/62 patients had androstenedione (A4) within the reference range, 13/62 showed elevated concentrations and 7/62 had suppressed concentrations. At the last available visit, 11/13 of patients with elevated A4 normalized. Salivary 17-hydroxyprogesterone decreased significantly in the early morning (p=0.025), 12 pm (p=0.036) and 4 pm (p=0.042). Median hydrocortisone-equivalent dose declined from 30 mg (IQR 25-37.5) to 25 mg (IQR 20-30) (p<0.001). HOMA-IR improved (2.15 to 1.67; p=0.023), while other metabolic parameters remained stable. Daytime blood systolic and diastolic pressure decreased by ∼5 mmHg (p=0.007 and p=0.003). Fludrocortisone was reduced in 12/41 (29.3%) salt-wasting patients. Among women with menstrual disturbances (12/42), 6/12 normalized and 1/12 conceived; among women with regular cycles, 3/12 developed irregular cycles or amenorrhea. The adrenal crisis rate was 5.0 per 100 patient-years. MR-HC enabled stable biochemical control with reduced glucocorticoid exposure and was associated with improvements in insulin sensitivity, blood pressure, and menstrual regularity, supporting its role as a safe and physiological treatment option in adults with CAH.

PMID 42156233
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PubMedThe Journal of veterinary medical science2026-05-14

Developmental and behavioral effects of fetal and neonatal exposure to the phenylpyrazole pesticide fipronil in mice.

Yoshimoto Ayano A, Nunobiki Sarika S, Ito Makiko M, Yonoichi Sakura S et al.

Fipronil (FPN), a phenylpyrazole pesticide widely used in agriculture and households, acts as a noncompetitive antagonist of gamma-aminobutyric acid (GABA)-gated chloride channels. Although originally considered relatively safe for mammals at low doses, FPN is metabolized into fipronil sulfone (FPNS), a more toxic and persistent metabolite. Both FPN and FPNS have been detected in human biological samples, raising concerns about chronic exposure during critical developmental windows. In this study, pregnant mice were administered FPN orally at 0.43 mg/kg/day from gestational day 1.5 through weaning. In Experiment 1, which was designed to evaluate fetal transfer, FPN and FPNS were detected in all fetal samples, with FPNS concentrations exceeding those of FPN and the levels of both compounds being higher in fetuses than in dams, suggesting placental transfer and fetal accumulation. In Experiment 2, behavioral and endocrine effects were assessed in male offspring at 3 and 10 weeks of age. Behavioral tests included the open field, elevated plus maze, and novel object recognition test. FPN-exposed offspring exhibited increased locomotor activity, reduced anxiety-like behavior, and impaired short-term memory and object recognition. Blood analyses revealed the presence of FPN and FPNS in exposed offspring, with FPNS levels peaking at 3 weeks. Histamine and progesterone levels were elevated at 3 weeks, while progesterone and 17-hydroxyprogesterone levels were decreased at 10 weeks. These findings suggest that fetal and neonatal exposure to FPN can disrupt neurobehavioral and endocrine development in mice.

PMID 42128844
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PubMedInternational journal of impotence research2026-05-14

Association between serum vitamin D and sex hormones in women: a cross-sectional analysis using NHANES Data (2021-2023).

He Yunan Y, Li Jinhong J, Qiu Jiahui J, Shi Qingquan Q

Most studies on the impact of vitamin D on sex hormones focus on specific populations, such as older males, Asian males, or those with certain health conditions. Limited evidence exists on the relationship between vitamin D and sex hormones in American women. This cross-sectional analysis used National Health and Nutrition Examination Survey (NHANES) data to explore the association between serum vitamin D levels and sex hormones levels in women. Data from NHANES (2021-2023) were analyzed. Participants were categorized by serum vitamin D levels: Deficient (<50 nmol/L), Insufficient (50-74.99 nmol/L), and Adequate ( ≥ 75 nmol/L). One-way ANOVA and Chi-square tests were used for comparisons, and linear regression evaluated associations. Our analysis specifically focused on a subset of 3181 women aged 18 years and older (18-80 years). Women in the adequate vitamin D group had lower body mass index (BMI) (29.16 vs. 32.10 kg/m², p < 0.001), lower total testosterone (24.10 vs. 32.28 ng/dL, p < 0.001), progesterone (139.05 vs. 229.73 ng/dL, p < 0.001), estrone sulfate (687.10 vs. 1023.08 pg/mL, p < 0.001), and dehydroepiandrosterone sulfate (DHEAS) (66.41 vs. 100.56 µg/dL, p < 0.001) compared to the deficient vitamin D group. They also had higher sex hormone-binding globulin (SHBG) (70.37 vs. 58.55 nmol/L, p < 0.001), follicle-stimulating hormone (FSH) (50.30 vs. 23.99 mIU/mL, p < 0.001), and luteinizing hormone (LH) (26.39 vs. 16.64 mIU/mL, p < 0.001) compared to the deficient vitamin D group. Linear regression revealed that higher serum vitamin D was inversely associated with 17α-hydroxyprogesterone (Beta = -0.85, P = 0.023), androstenedione (Beta = -0.181, p < 0.001), anti-Müllerian hormone (Beta = -0.238, p < 0.001), DHEAS (Beta = -0.204, p < 0.001), total testosterone (Beta = -0.080, P = 0.042), while showing a positive association with follicle-stimulating hormone (Beta = 0.260, p < 0.001) and luteinizing hormone (Beta = 0.208, p < 0.001). Serum vitamin D levels were negatively associated with testosterone and estradiol in American women, particularly in older individuals.

PMID 42129376
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PubMedInternational journal of molecular sciences2026-05-13

Microbiome-Derived Short-Chain Fatty Acids and Tryptophan Metabolites in Children with Autism Spectrum Disorder: A Stool-Urine Multi-Omics Analysis.

Osredkar Joško J, Fabjan Teja T, Godnov Uroš U, Jekovec-Vrhovšek Maja M et al.

Autism spectrum disorder (ASD) has been associated with alterations in the gut microbiota and its metabolites, particularly short-chain fatty acids (SCFAs) and microbiota-derived tryptophan catabolites, which may influence neurodevelopment through immune and epigenetic mechanisms. We investigated whether stool SCFAs and tryptophan-pathway metabolites differ between children with ASD and typically developing controls, and whether these metabolites associate with ASD severity and systemic biochemical signatures. In this cross-sectional study, we analyzed stool samples from 229 children (160 with ASD, 69 controls) with complete SCFA and tryptophan-metabolite data, while urine metabolomics data were available for a subset and were used for exploratory stool-urine integration analyses. Children with ASD and controls were similar in age, but the ASD group had a higher proportion of males. Absolute concentrations of individual SCFAs, total SCFAs, and derived indices were broadly comparable between groups; nominal differences in propionate/acetate ratio and caproate did not remain significant after false discovery rate correction. Similarly, stool tryptophan-pathway metabolites reported as ng/a.u. based on the NanoDrop-derived proxy (tryptophan, kynurenine, indole-3-acetic, indole-3-lactic, indole-3-propionic, indole-3-aldehyde, N-acetyl-tryptophan, serotonin, melatonin, tryptamine) and functional ratios (kynurenine/tryptophan, indole-derived/tryptophan, serotonin/tryptophan) showed no robust ASD-control differences; N-acetyl-tryptophan was nominally higher in ASD but did not survive multiple-testing correction. In the ASD subgroup with available Childhood Autism Rating Scale (CARS) data (n = 34), SCFA and tryptophan indices showed only weak, non-significant correlations with global ASD severity. In contrast, correlation analyses revealed two coherent metabolic modules, i.e., an SCFA block with very strong internal correlations among individual SCFAs and total SCFAs and a tryptophan block with strong correlations between metabolites and their normalized ratios, while cross-module correlations were modest. These results indicate that stool SCFA and microbiota-derived tryptophan profiles do not robustly distinguish ASD from controls in this cohort, but they form stable metabolic modules compatible with microbiome-epigenome frameworks.

PMID 42123569
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