Metabolic Disorders

ClinicalAugust 13, 2026

Alnylam Pharmaceuticals initiates Phase 1 trial for ALN-6222 in obesity

Alnylam Pharmaceuticals has launched Phase 1 clinical trial to evaluate ALN-6222 in adult participants with obesity, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy.

RegulatoryAugust 13, 2026

FDA accepts supplemental NDA for IQIRVO (elafibranor) by IPSEN

The FDA has accepted a supplemental NDA for IQIRVO (elafibranor) submitted by IPSEN, indicating a review process is underway.

RegulatoryAugust 10, 2026

FDA Approval Application for L-Glutamine by Annora Pharma

Annora Pharma submitted an original application (ANDA219722) for L-Glutamine, currently under standard review by the FDA.

ClinicalAugust 9, 2026

ACER-001 Study Initiated for MCADD in Pediatric and Adult Patients

A clinical trial is underway to evaluate sodium phenylbutyrate (ACER-001) for treating MCADD in patients aged 4 and older.

RegulatoryAugust 8, 2026

FDA Grants Approval for L-Glutamine Application ANDA219750

The FDA has granted approval for the L-Glutamine application submitted by STIRA under ANDA219750.

ClinicalAugust 3, 2026

AZD1043 Study Launches to Assess Safety and Pharmacokinetics in Overweight and Obese Adults

A clinical trial is underway to evaluate the safety, tolerability, and pharmacokinetics of AZD1043 in healthy adults with overweight and obesity.

RegulatoryAugust 2, 2026

FDA Approves Glycerol Phenylbutyrate Application by Lupin

The FDA has approved the application ANDA207694 for Glycerol Phenylbutyrate submitted by Lupin.

RegulatoryAugust 1, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Esjay Pharma

The FDA has granted approval for the ANDA220579 application for Glycerol Phenylbutyrate submitted by Esjay Pharma.

RegulatoryJuly 29, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Navinta LLC

The FDA has granted approval for the ANDA220568 application for Glycerol Phenylbutyrate submitted by Navinta LLC.

RegulatoryJuly 28, 2026

FDA Approves Sodium Acetate Application ANDA220274 by Extrovis

The FDA has approved the application ANDA220274 for Sodium Acetate submitted by Extrovis.

RegulatoryJuly 27, 2026

Aurobindo Pharma's Glycerol Phenylbutyrate Receives FDA Submission Approval

Aurobindo Pharma has received FDA submission approval for Glycerol Phenylbutyrate under application ANDA220313.

RegulatoryJuly 27, 2026

FDA Grants Approval for Glycerol Phenylbutyrate (ANDA219540)

The FDA has granted approval for Glycerol Phenylbutyrate under application ANDA219540, submitted by MSN.

RegulatoryJuly 27, 2026

FDA Grants Approval for Sodium Bicarbonate Application ANDA220788

The FDA has granted approval for the sodium bicarbonate application ANDA220788 submitted by ASPIRO.

RegulatoryJuly 26, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Teva Pharmaceuticals

Teva Pharmaceuticals has received FDA approval for Glycerol Phenylbutyrate under application ANDA218738.

ClinicalJuly 26, 2026

Alnylam's ALN-2232 Undergoing Evaluation for Obesity Treatment

A clinical trial is evaluating ALN-2232 for safety, efficacy, and pharmacokinetics in patients with obesity, including combination therapy with tirzepatide.

ClinicalJuly 24, 2026

Tianhuang Formula shows potential in addressing central insulin resistance

Tianhuang Formula enhances hypothalamic autophagy, potentially ameliorating insulin resistance and oxidative stress.

RegulatoryJuly 23, 2026

FDA Approves Supplement for PHEBURANE (NDA216513) by MEDUNIK

The FDA has approved a supplemental application for PHEBURANE, a treatment containing sodium phenylbutyrate.

ClinicalJuly 21, 2026

Boehringer Ingelheim's BI 764198 Trial Focuses on Safety and Pharmacokinetics

A clinical trial is underway to assess the safety and tolerability of BI 764198 in healthy men, alongside pharmacokinetic evaluations.

RegulatoryJuly 16, 2026

FDA Grants Approval for L-Glutamine ANDA219750 by Renova Pharms

The FDA has granted approval for the ANDA219750 application for L-Glutamine submitted by Renova Pharms.

RegulatoryJuly 16, 2026

FDA Grants Approval for Sodium Bicarbonate ANDA219089 by Milla Pharms

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 219089 for Sodium Bicarbonate submitted by Milla Pharms.

RegulatoryJuly 15, 2026

FDA Accepts NDA for Sodium Bicarbonate by Amneal EU Ltd.

The FDA has accepted the New Drug Application (NDA) for Sodium Bicarbonate submitted by Amneal EU Ltd.

RegulatoryJuly 11, 2026

Lupin's Glycerol Phenylbutyrate Receives FDA Approval Status

The FDA has granted an approval status of 'AP' for Lupin's application ANDA207694 for Glycerol Phenylbutyrate.

RegulatoryJuly 9, 2026

FDA Grants Approval for Levocarnitine ANDA217896 by Baxter Healthcare

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 217896 for Levocarnitine submitted by Baxter Healthcare.

RegulatoryJuly 4, 2026

Aurobindo Pharma's Glycerol Phenylbutyrate Application Receives FDA Review

Aurobindo Pharma has submitted an original application for Glycerol Phenylbutyrate under ANDA220313, which is currently under standard review by the FDA.

RegulatoryJuly 4, 2026

FDA Grants Approval for Glycerol Phenylbutyrate ANDA219540

The FDA has granted approval for the ANDA219540 application for Glycerol Phenylbutyrate submitted by MSN.

RegulatoryJuly 4, 2026

FDA Grants Approval for Sodium Bicarbonate ANDA220788 by ASPIRO

The FDA has granted approval for ANDA220788, a sodium bicarbonate formulation submitted by ASPIRO.

RegulatoryJuly 3, 2026

Teva's Glycerol Phenylbutyrate ANDA218738 Receives AP Status from FDA

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Glycerol Phenylbutyrate.

ClinicalJune 26, 2026

Akkermansia muciniphila MucT shows potential in improving insulin sensitivity in metabolic syndrome

A double-blind trial indicated that pasteurized Akkermansia muciniphila MucT improved insulin sensitivity and GLP-1 production in specific subgroups of adults with metabolic syndrome.

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Recent signals(28)

Alnylam Pharmaceuticals initiates Phase 1 trial for ALN-6222 in obesity

FDA accepts supplemental NDA for IQIRVO (elafibranor) by IPSEN

FDA Approval Application for L-Glutamine by Annora Pharma

ACER-001 Study Initiated for MCADD in Pediatric and Adult Patients

FDA Grants Approval for L-Glutamine Application ANDA219750

AZD1043 Study Launches to Assess Safety and Pharmacokinetics in Overweight and Obese Adults

FDA Approves Glycerol Phenylbutyrate Application by Lupin

FDA Grants Approval for Glycerol Phenylbutyrate by Esjay Pharma

FDA Grants Approval for Glycerol Phenylbutyrate by Navinta LLC

FDA Approves Sodium Acetate Application ANDA220274 by Extrovis

Aurobindo Pharma's Glycerol Phenylbutyrate Receives FDA Submission Approval

FDA Grants Approval for Glycerol Phenylbutyrate (ANDA219540)

FDA Grants Approval for Sodium Bicarbonate Application ANDA220788

FDA Grants Approval for Glycerol Phenylbutyrate by Teva Pharmaceuticals

Alnylam's ALN-2232 Undergoing Evaluation for Obesity Treatment

Tianhuang Formula shows potential in addressing central insulin resistance

FDA Approves Supplement for PHEBURANE (NDA216513) by MEDUNIK

Boehringer Ingelheim's BI 764198 Trial Focuses on Safety and Pharmacokinetics

FDA Grants Approval for L-Glutamine ANDA219750 by Renova Pharms

FDA Grants Approval for Sodium Bicarbonate ANDA219089 by Milla Pharms

FDA Accepts NDA for Sodium Bicarbonate by Amneal EU Ltd.

Lupin's Glycerol Phenylbutyrate Receives FDA Approval Status

FDA Grants Approval for Levocarnitine ANDA217896 by Baxter Healthcare

Aurobindo Pharma's Glycerol Phenylbutyrate Application Receives FDA Review

FDA Grants Approval for Glycerol Phenylbutyrate ANDA219540

FDA Grants Approval for Sodium Bicarbonate ANDA220788 by ASPIRO

Teva's Glycerol Phenylbutyrate ANDA218738 Receives AP Status from FDA

Akkermansia muciniphila MucT shows potential in improving insulin sensitivity in metabolic syndrome

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