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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

PubMedJournal of hazardous materials2026-10-14

Integrated mechanisms of progestogen degradation and stress resistance in Novosphingobium sp. ES2-1.

Li Shunyao S, Chen Peng P, Li Yaohui Y, Ye Naiyang N et al.

Environmental progestogens (Ps), precursors of various steroid hormones (SHs), can potentiate the endocrine-disrupting effects of SHs. Novosphingobium spp. are highly promising candidates for mitigating Ps contamination. Targeting progesterone (PGT), we found that N. sp. ES2-1 alleviated PGT-induced oxidative stress through metabolic glutathione synthesis, rerouting of electron transport entry points, and reduction of reactive oxygen species targets. PGT degradation initially proceeds via hydroxyprogesterone, following a metabolic pattern analogous to testosterone degradation. Through β-oxidation, this pathway ultimately yielded ring-cleavage products secophenol and 3aα-H-4α(3'-propanoate)-7aβ-methylhexahydro-1,5-indanedione. Cytochrome P450 and extradiol dioxygenase were identified as pivotal enzymes responsible for PGT structural modification and steroid skeleton cleavage. Proteins involved in iron acquisition, vitamin B6/B2 (VB6/VB2) biosynthesis interacted with β-oxidation-related proteins, suggesting that enzymes facilitating PGT skeleton cleavage required iron as an essential cofactor, while the necessary coenzymes and electron carriers relied on VB6/VB2. Seven putative PGT degradation genes encoding hydroxylases, dioxygenases, and dehydrogenases were proposed and harbored across four gene clusters that were significantly upregulated under PGT induction. These findings, for the first time, uncover the synergistic mechanisms in N. sp. ES2-1 where oxidative stress mitigation and optimized resources allocation supported PGT degradation, providing a theoretical framework for the rational engineering of SHs bioremediation strategies.

PMID 42874201
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PubMedEnvironmental health perspectives2026-10-09

17α-Hydroxyprogesterone Mediates Mo-Induced Sperm-Mediated Transgenerational Inheritance of Impaired Spermatogenesis.

Zhou Kun K, Song Xue X, Jiang Yingtong Y, Zhu Mengyuan M et al.

Growing evidence suggests that exposure to metals, such as molybdenum, contributes to significant health risks. However, very little is known about its potential male reproductive toxicity due to paternal exposure across generations. The aim of the present study was to investigate the male reproductive toxicity of paternal exposure to sodium molybdate (Na2MoO4) across generations and reveal the underlying mechanism. Adult F0 male C57 mice were administered sodium molybdate at doses of 0.01 and 0.1 mg/kg/day. The assessment included testicular toxicity evaluation and metabolomic profiling, followed by mechanistic studies in vivo and in vitro from F0 to F2. A large sample of case-control study including 958 subjects verified the findings. Reduced sperm counts and damages to seminiferous tubules across generations were observed in Mo-treated groups. Metabolomics analysis revealed a transgenerational elevation of 17α-hydroxyprogesterone (17α-OHP) in the testes of Mo-treated groups. Apoptosis and ferroptosis were enhanced in GC-2 cells in vitro after 17α-OHP treatment and were validated in vivo. Molecular competition experiments revealed that 17α-OHP competes for the NADPH binding site in FSP1, hindering FSP1's catalytic function, as supported by metabolomics analysis. Enzyme activity analysis found a reduction in FSP1 activity after 17α-OHP treatment, promoting ferroptosis and apoptosis in GC-2 cells in vitro. AHCY was identified as a potential target and was reduced after Mo exposure both in vivo and in vitro, accompanied by testicular DNA hypomethylation and elevated expression of key enzymes for 17α-OHP synthesis across generations, including Hsd3b and Cyp17a1. Human studies revealed that Mo exposure was associated with an increased risk of male infertility via 17α-OHP. This study innovatively elucidated the mechanisms by which paternal Mo exposure induced transgenerational male reproductive toxicity through metabolic and epigenetic alterations using human, mouse, and in vitro models.

PMID 42852385
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PubMedmSystems2026-10-08

Integrated multi-omics and metabolic modeling links structure to function in high-performing electrosynthetic biofilm communities.

Stroek Rozanne R, Gabriëls Minke M, Winkelhorst Marijn M, van den Broek Marcel M et al.

Microbial electrosynthesis (MES) is a promising technology for the valorization of CO2 into industrially relevant building blocks. The high-performing MES systems in terms of production rates of acetate (12.5-19.7 mmol L-1catholyte day-1), butyrate (1.9-12.2 mmol L-1catholyte day-1), and caproate (0.6-0.9 mmol L-1catholyte day-1) discussed in this study consist of mixed microbial communities. However, the microbial community members, metabolic pathways, and interactions driving product formation in MES communities remain poorly understood. To overcome these challenges, we conducted a comprehensive characterization of three high-performing MES communities, combining multi-omics with metagenome-scale metabolic modeling. Using a high-resolution metagenomic pipeline, we reconstructed high-quality genomes of 25 metagenome-assembled genomes present in our reactors, including six fully circular genomes. We report the presence of Clostridium aromativorans for the first time in a gas-fermenting system. In particular, our findings identified three acetogenic species, Eubacterium limosum, Sporomusa sphaeroides, and C. aromativorans, as key contributors to the production of acetate, butyrate, and caproate via the Wood-Ljungdahl and the reverse β-oxidation pathways. In addition, we found genes related to lactate and ethanol production from acetyl-CoA, along with proteomic evidence of lactate production. This paves the way for investigating the role of cross-fed metabolites such as lactate and ethanol as electron donors in chain elongation. Finally, meta-genome-scale metabolic modeling suggests that the communities might be sustained by the cross-feeding of specific cofactors such as pyridoxine, pantothenate, biotin, and thiamin. This study provides key insights into the structure and function of electrosynthetic communities, bringing us closer to the rational engineering of MES systems.IMPORTANCEMicrobial electrosynthesis (MES) offers a promising route to transform CO2 and renewable electricity into valuable platform chemicals. However, the microbial ecology governing the assembly and function of these systems remains poorly understood, limiting our ability to engineer them. By integrating high-resolution multi-omics with metabolic modeling, this study provides a systems-level framework to dissect the structure and function of electrosynthetic microbial communities. Understanding which organisms drive carbon fixation and chain elongation, how electrons and intermediates are transferred within the biofilm, and how metabolic dependencies structure these communities is essential for improving productivity and product specificity in MES. More broadly, this work highlights how integrated multi-omics approaches can resolve the functional organization of complex microbial ecosystems and provides methodological advances that are broadly applicable to the study and engineering of microbial communities in autotrophic, electricity-driven biotechnologies.

PMID 42847688
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PubMedMicrobial cell factories2026-09-30

Fecal microbiota fermenting simple organic carbon substrates in vitro as microbial factories capable of distinguishing Crohn's disease from healthy states.

Detman-Ignatowska Anna A, Schiro Gabriele G, Filip Rafał R, Samborowska Emilia E et al.

Crohn's disease (CD) is characterized by low microbial richness and diversity of the gut microbiome, shifts in the abundance of specific taxa, reduced presence of C2-C6 organic acid producers, especially butyrate-forming bacteria, and alterations in gut metabolites. This study aimed to demonstrate differences in the dynamics and fermentation activity of the fecal microbiota of CD patients and healthy individuals (HIs) grown in vitro on glucose or a mixture of acetate and lactate (fecal microbiota batch cultures). Glucose was used as a substrate for glycolytic fermentation, whereas a mixture of acetate and lactate supported related pathways leading to the production of C2-C6 organic acids, particularly butyrate via the conversion of lactate and acetate. HI fecal microbiota cultures produced butyrate mainly through lactate and acetate transformation rather than via glucose fermentation. This pathway was impaired in the CD fecal microbiota cultures, which exhibited reduced synthesis of butyrate, valerate, caproate and propionate, and excessive production of ethanol and certain amino acids. These distinct fermentation activities stemmed from differences in the original CD and HI fecal microbiota composition that were further accentuated in batch cultures. The number of beneficial commensal bacteria (e.g., Coprococcus catus, Ruminococcus torques, Gemmiger formicilis, Eubacterium rectale, Fusicatenibacter saccharivoransi, Faecalibacterium prausnitzii) were significantly lower in the CD fecal microbiota cultures and correlated with reduced butyrate, valerate and caproate levels. Conversely, an overabundance of the recognized CD dysbiosis-associated bacteria, such as Escherichia coli, was reflected in elevated ethanol and amino acid levels in post-fermentation liquids. Metabolic potential analysis further indicated an enrichment of genes encoding enzymes involved in ethanol and amino acid biosynthesis in CD fecal microbiota cultures and highlighted the metabolic versatility of E. coli. Fermentation patterns of fecal microbiotas in batch cultures can distinguish CD-associated dysbiosis from a healthy microbiome, with particular emphasis on lactate and acetate conversion to butyrate as a key pathway of butyrate production. The differences are observed under standardized in vitro conditions without the need to reconstruct the intestinal environment. These findings, pending further validation, may offer novel diagnostic opportunities and have implications for strategies aimed at restoring a healthy gut microbiome.

PMID 42811337
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PubMedEndocrine2026-09-28

Newborn screening for congenital adrenal hyperplasia: a 3 years study embedded in 25 years of regional experience in Italy.

Tuli Gerdi G, Munarin Jessica J, Pavanello Enza E, De Sanctis Luisa L

Newborn screening for congenital adrenal hyperplasia (CAH) using 17-hydroxyprogesterone (17-OHP) is hampered by high false-positive rates, especially in preterm and low birth weight infants. Second-tier strategies aim to improve specificity, but population-based data are limited. The aim was to evaluate CAH screening approach using birth weight-adjusted cut-offs and repeated sampling in a large regional cohort. We analyzed data from 90,092 infants screened in Piedmont, Italy (2019-2022). 17-OHP was measured in dried blood spots, with birth weight-adjusted thresholds and repeated sampling when indicated. 17-OHP distributions were examined by birth weight and gestational age, and outcomes assessed via recall rate and confirmed diagnoses. Of 90.092 infants, 746 were recalled (0.82%), and 119 referred for specialist evaluation. Eight infants were diagnosed with classic salt-wasting CAH and one with non-classical CAH (incidence 1:11.261). 17-OHP concentrations inversely correlated with birth weight, capturing most biological variability. Repeated sampling significantly reduced false positives across all birth weight categories. Gestational age stratification offered no clear advantage over birth weight-based thresholds. Birth weight-based CAH screening effectively lowers false positives while identifying classic CAH. Refining percentile-informed cut-offs, particularly in higher birth weight infants, could further enhance efficiency without compromising safety.

PMID 42803878
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PubMedMedicina (Kaunas, Lithuania)2026-09-26

Transition from Pediatric to Adult Endocrine Care in Patients with Congenital Adrenal Hyperplasia: A Single-Center Retrospective Analysis.

Mercan Sarıdaş Filiz F, Karatoprak Kadircan K, Nursoy Hatice H, Hocaoğlu Erhan E et al.

Background and Objectives: The transition from pediatric to adult endocrine care represents a vulnerable period for patients with congenital adrenal hyperplasia (CAH), given the risk of loss to follow-up and the evolving physiological and healthcare requirements associated with the transition to adulthood. This study aimed to compare structured and non-structured transition pathways in patients with CAH, focusing on the continuity of adult endocrine care and disease-specific hormonal, clinical, and treatment-related outcomes. Materials and Methods: This single-center, retrospective, observational study included patients with CAH who transitioned from pediatric to adult endocrine care and met predefined pediatric and adult follow-up eligibility criteria. Patients were classified according to whether the transition occurred through a structured multidisciplinary transition program or without participation in the structured program. Outcomes were evaluated during predefined observation periods before and after transfer and included continuity-of-care measures, 17-hydroxyprogesterone (17-OHP) and androstenedione concentrations, achievement of predefined hormonal targets, body mass index (BMI), glucocorticoid and mineralocorticoid treatment, and CAH-related clinical outcomes. Results: Among 67 patients assessed for eligibility, 29 were included: 20 in the structured transition group and 9 in the non-structured transition group. Overall, 62.1% of the study population was female. No significant between-group differences were observed in continuity-of-care measures, including the pediatric-to-adult care gap, first-year adult visit frequency, maximum visit-free interval, first-year loss to follow-up, or active adult endocrine follow-up at the study cutoff. Pre-transition and post-transfer 17-OHP and androstenedione concentrations and achievement of predefined hormonal targets did not differ significantly between groups. No significant longitudinal changes in hormonal outcomes, BMI, or body-surface-area-adjusted hydrocortisone-equivalent glucocorticoid doses were observed within either group. At the study cutoff, 85.0% of patients in the structured group and 77.8% in the non-structured group remained under active adult endocrine follow-up. Conclusions: In this small single-center cohort, no significant differences in the continuity of adult endocrine follow-up or disease-specific outcomes were observed between structured and non-structured transition pathways. Most patients remained engaged with adult endocrine care, and hormonal control showed no evident deterioration following transfer in either group. Given the small sample size and high overall retention, these findings should not be interpreted as evidence of equivalence between the two transition approaches.

PMID 42796361
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