This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.

Start Date10 Sep 2026

Sponsor / Collaborator-

NCT07191028

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parellel-group Study to Assess the Efficacy and Safety of MLC901 (NeuroAiD™II) in Subjects With Mild to Moderate Alzheimer's Disease (AD).

ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo.

Start Date01 Aug 2026

Sponsor / Collaborator

Moleac Pte Ltd.

[+1]

NCT04861688

/ CompletedPhase 3

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II™ (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

Start Date23 Aug 2021

Sponsor / Collaborator

Moleac Pte Ltd.

100 Clinical Results associated with MLC901

100 Translational Medicine associated with MLC901

100 Patents (Medical) associated with MLC901

Literatures (Medical) associated with MLC901

01 Mar 2026·Pakistan Journal of Pharmaceutical Sciences

The Efficacy Of MLC 901 In Neuron-Specific Enolase, Functional Outcome And Cerebral Infarct Volume For Acute Ischemic Stroke Model In Rats

Article

Author: Tammasse, Jumraini ; Vidya Lestari, Rizka ; Hunaifi, Ilsa ; Dyah Cahyawati, Triana ; Wahid, Isra ; Surya Pratama, Iman ; Kurnia Bintang, Andi

Background: Ischemia causes neuronal death and releases Neuron-Specific Enolase (NSE). Thrombolysis is a standard therapy for ischemic stroke, but only 10-20 percent of patients receive thrombolysis. It is necessary to develop a treatment to increase neuroprotection by administering MLC 901 to influence NSE levels. Objectives: The study investigates the efficacy of MLC 901 on NSE levels, functional outcome and infarct volume in the stroke model of rats. Methods: Male Wistar rats were divided into acute ischemic stroke with MLC 901 43.2 mg/body weight, acute ischemic stroke with MLC 901 21.6 mg/body weight and acute ischemic stroke with CMC-Na for placebo-all treatment for 14 days. The NSE level was determined by ELISA, functional outcome determined by motoric score and infarct volume using NIH Image J. Results: NSE level increased at 24 hours after stroke. There was no difference in administering the dose of MLC 901 to improve functional outcome and reduce cerebral infarct volume. Conclusion: MLC 901 improved functional outcomes and reduced the volume of cerebral infarction in acute ischemic stroke but did not affect NSE levels.

01 Oct 2025·Stroke and Vascular Neurology

Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol

Article

Author: Lokin, Johnny K ; Tham, Carol Huilian ; De Silva, Deidre Anne ; Koh, Yeow-Hoay ; Esagunde, Romulo U ; Venketasubramanian, Narayanaswamy ; Lao, Annabelle Y ; Escabillas, Cyrus G ; Hiyadan, John Harold ; Advincula, Joel M ; Chen, Christopher P L H ; Collantes, Maria Epifania V ; Co, Christian Oliver C

Background:

MLC1501, consisting of four herbs, that is, Radix Astragali , Radix Angelicae sinensis , Rhizoma Chuanxiong , Radix Polygalae , has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective, anti-inflammatory and neurorestorative properties in non-clinical models, as well as clinical benefits in improving functional and neurological recovery after brain injuries.

Aims:

To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment (FMA) total score at 24 weeks in patients with ischaemic stroke (IS).

Design:

A total of 300 patients aged >18 years, diagnosed with IS in the prior 2–10 days, with National Institute of Health Stroke Scale (NIHSS) total score of 8–18 and a combined score of ≥3 on NIHSS motor items 5A, 5B, 6A and/or 6B, will be randomised in a 1:1:1 ratio to receive oral placebo, MLC1501 low dose or MLC1501 high dose for 6 months. The study is governed by a Steering Committee. An independent Data Monitoring Committee oversees patient safety.

Outcomes:

The primary outcome is mean change from baseline in FMA total score at 24 weeks. Efficacy outcomes evaluated in person at baseline, 12 weeks and 24 weeks include the FMA (total, upper extremity and lower extremity motor scores), modified Rankin Scale (mRS), Patient-Reported Outcomes Measurement Information System–Global Health (PROMIS-10) and NIHSS. Additionally, telephone assessment at week 4 includes the simplified mRS and PROMIS-10.Safety will be evaluated by standard assessments and occurrence of adverse events over the duration of the study.

Discussion:

Interventions that enhance recovery beyond the acute period of stroke are needed. MLC1501 has a good safety profile as well as potential to be a treatment for recovery after brain injury. The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.

Trial registration number:

NCT05289947 .

30 Jun 2025·Asian Spine Journal

Inhibitory effect of MLC901 on axonal demyelination in experimental animals undergoing circumferential lumbal stenosis by increasing transforming growth factor-β1 levels

Article

Author: Priyanto, Bambang ; Islam, Andi Asadul ; Qanitha, Andriany ; Sjukur, Kevin Jonathan ; Adhimarta, Willy

Study Design: Experimental study using circumferential lumbar stenosis (CLS) rat model.Purpose: To investigate the effect of MLC901 administration on transforming growth factor (TGF)-β1 level and the degree of axonal demyelination in the CLS rat model.Overview of Literature: CLS is common in older adults, causing neuropathic pain that impairs daily functioning. TGF-β1 plays an essential role in nerve regeneration and reducing axonal demyelination in CLS. MLC901, a traditional therapeutic formula, has shown promise in preclinical studies, including modulating proinflammatory cytokines. While MLC901’s effect on serum TGF-β1 levels in the CLS rat model has been explored, its impact on tissue TGF-β1 expression remains understudied.Methods: Rats were randomly allocated into one of six groups: no CLS (baseline), CLS only (pretreatment), short treatment (1 day) with MLC901, short treatment with placebo, longer treatment (7 days) with MLC901, and longer treatment with placebo. The CLS model was induced by laminectomy at the lumbar 5th vertebra, followed by teflon insertion around the dura mater. Serum TGF-β1 levels were measured using enzyme-linked immunosorbent assay. Tissue TGF-β1 expression and the degree of axonal demyelination were assessed by immunohistochemistry and histopathology, respectively.Results: Long treatment MLC901 group had significantly higher serum TGF-β1 levels than the pretreatment group (p<0.001). Long treatment MLC901 group also exhibited the highest TGF-β1 tissue expression among all treatment groups, including the baseline group (<i>p=0.013). Axonal demyelination was lowest in the long treatment MLC901 group, indicated by the highest number of Schwann cells (p<0.001), the fewest inflammatory cells (except versus baseline) (<i>p=0.001), and the fewest vacuoles (except versus baseline) (p=0.015).Conclusions: MLC901 can inhibit axonal demyelination in experimental animals undergoing CLS surgery by upregulating TGF-β1 levels. MLC901 has the potential to be used as an adjuvant therapy in CLS surgery.

News (Medical) associated with MLC901

21 Oct 2024

·www.prnewswire.com

Moleac Announces PT Ferron Par Pharmaceuticals as New Exclusive Partner in Indonesia

SINGAPORE, Oct. 21, 2024 /PRNewswire/ -- Moleac is excited to announce a significant milestone in the journey of NeuroAiD II MLC901 as PT Ferron Par Pharmaceuticals will become our exclusive partner in Indonesia effective Jan 1st 2025. We are immensely grateful for the fruitful 12-year partnership with PT Mersifarma Tirmaku Mercusana, and we sincerely thank them for their invaluable contributions to our success in Indonesia. As we embark on a new chapter, we are thrilled to welcome PT Ferron Par Pharmaceuticals — a member of Dexa Group — as our new exclusive commercial partner. This partnership marks a crucial milestone in our mission to widen access to our groundbreaking products, supporting healthcare professionals in enhancing outcomes for patients recovering from stroke, traumatic brain injuries, and neurodegenerative diseases. With PT Ferron Par Pharmaceuticals, a leader renowned for its market expertise and operational excellence, we are confident in our accelerated growth and the expanded availability of NeuroAiD II MLC901 to those in need. We look forward to a future of growth and continued innovation as we extend the reach of NeuroAiD II MLC901 in Indonesia to benefit more patients. About Moleac Moleac is a biopharmaceutical company that stays committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering a loss of brain function after brain injuries or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. For further information, visit moleac.com. About PT Ferron Par Pharmaceuticals PT Ferron Par Pharmaceuticals, a member of Dexa Group, is a fast growing pharmaceutical company that started its operation in 2001. Ferron has become one of the 20 largest pharmaceutical operations in Indonesia (Combined IHPA+IPA 2005, IMS Audit). With a diverse product portfolio, advanced manufacturing capabilities, and strong partnerships, Ferron continues to strengthen its market presence and operational excellence. For more information, visit dexagroup.com. SOURCE Moleac WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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06 Jun 2022

·www.prnewswire.com

NeuroAiD has shown favourable outcome in patients suffering from spinal cord injuries

SATURN study aimed at assessing the safety and effects of a 6-month course of NeuroAiD (MLC601/MLC901) to augment functional and motor recovery after severe spinal cord injury (SCI). NeuroAiD was safe as add-on treatment in patients with severe SCI. One third of patients improved on ASIA Impairment Scale (AIS) grading with corresponding motor recovery at month 6. SINGAPORE, June 6, 2022 /PRNewswire/ -- Moleac is pleased to announce the release of the results of the SATURN study1 published online in the Journal of Spinal Cord Medicine . Spinal cord injury (SCI) carries debilitating consequences with severe neurological and functional deficits, deteriorating the quality of life for survivors and their relatives. To date, there is no way to reverse spinal cord damage, and new treatments are always sought, including prostheses, devices and medications, to improve motor function and function recovery in SCI. NeuroAiD has well established neuroprotective and neurorepair properties that enhance neurological recovery on top of rehabilitation in stroke and traumatic brain injury. It could represent a new therapeutic approach for SCI patients. SATURN (Spinal cord injury Assessing Tolerability and Use of combined Rehabilitation and NeuroAiD) study was designed to evaluate the safety and potential role of NeuroAiD in subjects suffering from severe SCI. This pilot study included 30 subjects with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A and B, who received a 6-month course of NeuroAiD on top of standard care and rehabilitation. The key endpoints were the safety profile by measuring the occurrence of adverse events (AEs) during the 6-month course of NeuroAiD and the improvements in the AIS grade and motor score at month 6. Key findings: A total of 14 AEs were reported by 10 patients, none being deemed definitely, likely or possibly related to NeuroAiD. 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. One patient has even achieved complete recovery (grade E). The Asia total motor score improved over time from 17.1 at baseline to 49.9 at month 6. Of note, the investigators pointed out that the improvement rates during the 6-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A. "Any improvement in AIS grading is clinically important for SCI patients," said Prof. Ramesh Kumar, neurosurgeon at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. "The rates of improvement we saw at 6 months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option." NeuroAiD shows a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries. ACCESS THE ARTICLE HERE About NeuroAiD NeuroAiD is a 9 component-herbal supplements that is carries the neuroprotective and neurorestorative properties. Multiple clinical studies were conducted in NeuroAiD showing efficacy in stroke, and patients with traumatic brain injuries. About Moleac Moleac is a biopharmaceutical company committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering from a loss of brain functions after a brain injury or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. NeuroAiDTM and NurAiDTM are trademarks of Moleac. MLC601 (NeuroAiDTM) and MLC901 (NeuroAiDTMII/NurAiDTMII) are two different proprietary formulae which have been shown to be equivalent in pharmacology and are referred as "NeuroAiD" in this document. Ramesh Kumar et al. Spinal cord injury – assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study – primary results of an exploratory study. The Journal of Spinal Cord Medicine. May 2022, DOI: 10.1080/10790268.2022.2067972. For more information, contact [email protected] SOURCE Moleac

100 Deals associated with MLC901

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Brain Injuries, Traumatic	Singapore	Moleac Pte Ltd.	-
Cognitive Dysfunction	Singapore	Moleac Pte Ltd.	-
Spinal Cord Injuries	Singapore	Moleac Pte Ltd.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	Singapore	Moleac Pte Ltd.	01 Aug 2026
Brain Concussion	Phase 3	Russia	Moleac Pte Ltd.	23 Aug 2021
Brain Infarction	Phase 2	Singapore	Moleac Pte Ltd.	01 Jan 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCN2025	Not Applicable	Cognitive Dysfunction	82	MLC901 (NeuroAiD II)	wwusjdrxqm(cjjvpwgzzc) = Two patients reported nausea wavqtyfktf (ozzhjumxeu ) View more	Positive	12 Oct 2025
NCT04861688 (MLC901, Pubmed \| PLoS One)	Phase 3	Brain Concussion	182	MLC901 (NeuroAiDTMII) (MLC901)	egyxwrdasf(cbsvxaljux): P-Value = 0.58 View more	Positive	10 Jul 2025
				MLC901 (NeuroAiDTMII) (Placebo)
NCT03038035 (ATHENE, CTAD2022)	Phase 2	Alzheimer Disease Add-on	125	MLC901 (NeuroAiD-II)	yzrqehhtum(mnfdjlfnyq) = xrhhowvuzy pbhnktragq (hdngcsvuyz, -6.06 to -1.28)	Positive	03 Dec 2022
				Placebo	-
NCT00554723 (CHIMES, Pubmed \| Stroke)	Phase 3	Stroke	1,100	MLC601	kodhgihfir(ajrqlllkzp): adjusted odds ratio = 1.09 (95% CI, 0.86 - 1.32)	Negative	01 Aug 2013
				Placebo

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