pharma · PCOS · Stomach Neoplasms
RenJi Hospital
RenJi Hospital is a pharma organization headquartered in CN. Primary therapeutic focus areas include PCOS, Stomach Neoplasms. NovaPharmaNews links 2 clinical program(s), 0 drug profile(s), and 0 patent record(s) to this
Approved · small molecule · PCOS
Acarbose 100 MG is a small-molecule oral alpha-glucosidase inhibitor developed by RenJi Hospital for the treatment of polycystic ovary syndrome (PCOS). The drug works by inhibiting pancreatic alpha-amylase and targeting maltase-glucoamylase, mechanisms that slow carbohydrate digestion and absorption. Acarbose is an est
Internal code [2017]055
Acarbose 100 MG is a small-molecule oral alpha-glucosidase inhibitor developed by RenJi Hospital for the treatment of polycystic ovary syndrome (PCOS). The drug works by inhibiting pancreatic alpha-amylase and targeting maltase-glucoamylase, mechanisms that slow carbohydrate digestion and absorption. Acarbose is an established pharmaceutical entity with multiple approved formulations globally; this program represents a clinical investigation of its efficacy in PCOS management, a condition characterized by insulin resistance and metabolic dysfunction. The program is currently in active status with an approved phase designation, indicating completion of clinical development in the China setting. The latest milestone was recorded on 26 December 2017. RenJi Hospital is sponsoring this investigation independently without disclosed external partnerships. Regulatory approval has been achieved in Australia and the United States under multiple manufacturers including Viatris, Bayer Healthcare, and others. The clinical trial NCT03383068 is registered in China, reflecting the geographic focus of this particular program investigation.
PCOS is a prevalent endocrine disorder affecting reproductive-age women, characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. Insulin resistance is present in 50–70% of PCOS patients and is a key pathogenic mechanism. Current PCOS management relies on lifestyle modification, hormonal contraceptives, and insulin-sensitizing agents such as metformin; however, therapeutic options remain limited and many patients experience inadequate symptom control or medication intolerance. Acarbose's mechanism of reducing postprandial glucose and insulin levels offers a potential non-hormonal, metabolic approach to PCOS management, particularly for insulin-resistant phenotypes. The market relevance is substantial given the high prevalence of PCOS (estimated 6–20% of reproductive-age women depending on diagnostic criteria) and the chronic nature of the condition requiring long-term pharmacotherapy. This program's investigation in a Chinese population addresses a significant unmet need in a large patient population. Competitive positioning against placebo and other investigational agents (AREG-TRIGGER) suggests a focus on establishing clinical evidence for acarbose's efficacy in this off-label indication. Commercial significance is moderate, as acarbose is already a mature, off-patent product; however, a positive trial could expand its clinical use and market penetration in PCOS management across Asia and potentially globally.
Drug Class: Alpha-glucosidase inhibitor (carbohydrate absorption inhibitor)
Mechanism of Action: Pancreatic alpha-amylase inhibitor targeting maltase-glucoamylase; delays glucose absorption in the small intestine, reducing postprandial hyperglycemia and hyperinsulinemia.
Modality: Small molecule
Route of Administration: Oral
Target: Maltase-glucoamylase enzyme complex
Formulation: 100 mg tablet
Brand Name: Acarbose Viatris (among multiple approved brands)
Related Therapies: Other alpha-glucosidase inhibitors (miglitol, voglibose); insulin sensitizers (metformin, thiazolidinediones); GLP-1 receptor agonists
Regulatory History: Acarbose was first approved in the United States under NDA020482 and has since been approved by the FDA under multiple abbreviated new drug applications (ANDAs) by various manufacturers. In Australia, acarbose is listed on the ARTG with PBS codes and multiple sponsors including Alphapharm Pty Ltd and Arrow Pharma Pty Ltd, with first listings dating to 2016 and subsequent updates through 2023.
Also known as: PCOS, Stein-Leventhal syndrome, polycystic ovarian disease, polycystic ovaries, PCOS1, polycystic ovary syndrome 1
A disorder that manifests as multiple cysts on the ovaries. It results in hormonal imbalances and leads to irregular and abnormal menstrual periods, excess growth of hair, acne eruptions and obesity.
ClinicalTrials.gov lists 621 registered studies for Polycystic Ovary Syndrome, (AACT aggregate).
Phase breakdown: NA (408), PHASE4 (84), PHASE3 (43), PHASE2 (25), EARLY_PHASE1 (22), PHASE1 (15), PHASE1/PHASE2 (12), PHASE2/PHASE3 (12)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0008487), Orphanet — polycystic ovary syndrome, NCT00004311, NCT00005104, NCT00005459, NCT00005654, NCT00037245, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Latest program milestone
Program status recorded as active and approved as of 26 December 2017; specific milestone details not yet disclosed.
The competitive landscape for this PCOS investigation includes placebo as the primary comparator and AREG-TRIGGER, an investigational small-molecule therapy developed by Hospital Authority, Hong Kong, currently in development. Placebo is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., indicating a structured clinical trial design. AREG-TRIGGER represents a novel small-molecule competitor also targeting PCOS, though its specific mechanism and development stage are not fully detailed in available data. Acarbose's competitive position rests on its established safety profile, oral route of administration, and mechanism targeting insulin resistance—a core PCOS pathophysiology. Unlike newer investigational agents, acarbose benefits from decades of clinical use in diabetes management, potentially offering a lower-risk profile. However, the program faces competition from metformin, which is standard-of-care for insulin-resistant PCOS, and emerging GLP-1 receptor agonists showing promise in metabolic PCOS phenotypes. The trial design comparing acarbose to placebo suggests the sponsor is building evidence for a previously off-label indication rather than positioning against established competitors.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| placebo | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., | other | development |
| AREG-TRIGGER | Hospital Authority, Hong Kong | small_molecule | development |
| CLOMIPHENE CITRATE | — | Estrogen receptor alpha modulator | Approved |
| SIMVASTATIN | — | HMG-CoA reductase inhibitor | Phase 3 |
| SAXAGLIPTIN ANHYDROUS | — | Dipeptidyl peptidase IV inhibitor | Phase 3 |
| RALOXIFENE | — | Estrogen receptor beta modulator | Phase 3 |
| METFORMIN | — | Mitochondrial complex I (NADH dehydrogenase) inhibitor | Phase 3 |
| MENOTROPINS | — | Follicle stimulating hormone receptor agonist | Phase 3 |
| LIRAGLUTIDE | — | Glucagon-like peptide 1 receptor agonist | Phase 3 |
| LETROZOLE | — | Cytochrome P450 19A1 inhibitor | Phase 3 |
| GONADOTROPIN, CHORIONIC | — | Luteinizing hormone/Choriogonadotropin receptor agonist | Phase 3 |
| ETHINYL ESTRADIOL | — | Estrogen receptor alpha agonist | Phase 3 |
| ERGOCALCIFEROL | — | Vitamin D receptor agonist | Phase 3 |
| ENCLOMIPHENE | — | Estrogen receptor alpha modulator | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States: Acarbose is approved by the FDA. Multiple ANDA approvals exist (ANDA077532, ANDA078441, ANDA078470, ANDA090912, ANDA091053, ANDA091343, ANDA202271, ANDA213821) and one NDA (NDA020482), with sponsors including Avet Lifesciences, Bayer Healthcare, Hangzhou Zhongmei, Hikma, Impax Labs, Natco Pharma USA, Somerset Therapeutics, Strides Pharma, and Watson Labs.
Australia: Acarbose is approved and listed on the ARTG with PBS codes 13869Y, 13955L, 8188Y, and 8189B. Sponsors include Alphapharm Pty Ltd and Arrow Pharma Pty Ltd, with first listed dates of 1 September 2016, 1 February 2023, and 1 August 2023.
China (NMPA): Acarbose is currently in clinical trials status in China. NCT03383068 is registered and reflects investigational use of acarbose 100 MG for PCOS in the Chinese population.
European Medicines Agency (EMA): Regulatory status not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
This program investigates acarbose 100 MG for the treatment of polycystic ovary syndrome (PCOS), a condition characterized by insulin resistance, hormonal imbalance, and ovulatory dysfunction.
Acarbose is a pancreatic alpha-amylase inhibitor that targets maltase-glucoamylase, slowing carbohydrate digestion and absorption in the small intestine, thereby reducing postprandial glucose and insulin levels.
Yes, acarbose is approved globally for type 2 diabetes management. It is approved by the FDA in the United States, listed on the ARTG in Australia, and has multiple manufacturers marketing approved formulations worldwide.
RenJi Hospital is the sponsor of this acarbose 100 MG PCOS program. No external commercial partner has been disclosed.
The program is in active status with an approved phase designation, indicating completion of clinical development. The latest milestone was recorded on 26 December 2017.
NCT03383068 is the registered clinical trial investigating acarbose 100 MG for PCOS. The trial is being conducted in China.
Results of NCT03383068 have not yet been reported in the available data. The trial status and outcome data are not yet disclosed.
Acarbose 100 MG is administered orally as a tablet.
Acarbose inhibits pancreatic alpha-amylase and targets maltase-glucoamylase, delaying glucose absorption and reducing postprandial hyperglycemia and hyperinsulinemia.
Competitors identified in the trial include placebo (sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co.) and AREG-TRIGGER (a small-molecule investigational therapy developed by Hospital Authority, Hong Kong).
Acarbose is not yet approved specifically for PCOS treatment. This program is investigating its efficacy and safety in PCOS as an off-label indication.
Acarbose is currently in clinical trials status in China, as reflected by NCT03383068. Regulatory approval for PCOS indication has not been disclosed.
Acarbose is approved by the FDA in the United States under multiple ANDA applications and one NDA (NDA020482), with multiple manufacturers marketing approved formulations.
Acarbose is approved in Australia and listed on the ARTG with PBS codes. Multiple sponsors including Alphapharm Pty Ltd and Arrow Pharma Pty Ltd market approved formulations.
Acarbose's mechanism of reducing postprandial glucose and insulin levels addresses insulin resistance, a core pathophysiologic feature of PCOS, offering a potential non-hormonal metabolic treatment option.
PCOS affects 6–20% of reproductive-age women and current management relies primarily on hormonal contraceptives and metformin; many patients experience inadequate symptom control or medication intolerance, creating a need for additional therapeutic options.
Acarbose 100 MG → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: RenJi Hospital's sponsorship of this PCOS investigation reflects a strategy to generate clinical evidence for an established drug in a new indication, a cost-effective development approach. The 2017 milestone date suggests this program may have completed enrollment or reached a key interim analysis point; however, publication of results has not been disclosed, limiting visibility into efficacy and safety outcomes.
Competitive Implications: If positive, this trial could position acarbose as a non-hormonal metabolic option for PCOS management in Asia, potentially expanding market share in a region with high PCOS prevalence. However, the mature, off-patent status of acarbose limits commercial upside compared to novel therapeutics. Metformin remains the entrenched standard-of-care; acarbose would likely serve as an adjunctive or alternative therapy for metformin-intolerant or metformin-inadequate responders.
Future Catalysts: Publication of NCT03383068 results in peer-reviewed literature; regulatory submissions to NMPA or other Asian health authorities based on trial data; potential label expansion or clinical guideline inclusion in PCOS management algorithms; expansion of the trial to additional geographic regions or populations.
Expected Milestones: Next milestone date not yet disclosed. Anticipated catalysts include trial result publication, regulatory feedback from NMPA, and potential post-marketing surveillance data if approved for PCOS indication in China.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.