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amphotericin B (Amphomul)

✓ Approved

Bharat Serums and Vaccines Limited · Small Molecule · Small Molecule

What is amphotericin B?

amphotericin B is a small molecule developed by Bharat Serums and Vaccines Limited. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesAmphomul
CompanyBharat Serums and Vaccines Limited
Drug ClassSmall Molecule
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Bharat Serums and Vaccines Limited

Therapeutic Indications

amphotericin B is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsLeishmaniasis✓ Approved
Infections and infestationsWound infection fungal✓ Approved

Related Research Articles

PubMedNature medicine2026-10-15

Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial.

Sellars MacLean C MC, Frank Jessica A JA, Shim Bohoon B, Vanasse Allison A et al.

Personalized neoantigen-targeting cancer vaccines in the adjuvant setting are of increasing interest across malignancies. Here we report the results of a phase 1 clinical trial testing the feasibility and safety of personalized neoantigen-targeting cancer vaccines for high-grade epithelial ovarian cancer. 'NeoVax' consisted of pools of synthetic long peptides targeting patient-specific neoantigens admixed with the immunostimulant poly-ICLC, was combined with delayed administration of anti-PD-1 antibody, and was tested in ten patients (one newly diagnosed patient (Cohort A) and nine patients at first recurrence (Cohort B)) with platinum-sensitive ovarian cancer following standard-of-care platinum doublet chemotherapy. Nine of 12 evaluable Cohort B patients were vaccinated (75%, 90% CI 47-93%) and 1 of 9 Cohort A patients (11%, 90% CI 0.6-43%). No unexpected safety signals were encountered and no patients discontinued treatment due to toxicity. Across patients, >70% selected targets remained detectable by noninvasive cell-free DNA analysis despite a median of 6.5 months from the time of diagnostic biopsy to vaccine administration, during which, patients received standard-of-care chemotherapy. Biomarker analysis was suggestive of biologic activity of the vaccine in six of ten patients and this was associated with broader tumor and vaccine-specific immune responses in blood and tumor following vaccination. Resistant tumor clones reflected diverse mechanisms affecting antigen presentation, indicative of immune-selective pressure exerted by vaccination. Overall, the interplay between the repertoire of antigens presented by the tumor and the breadth of induced immunity seemed to dictate clinical efficacy following vaccination. ClinicalTrials.gov identifier: NCT04024878 .

PMID 42875558
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PubMedInfectious diseases and therapy2026-10-15

A Phase 2 Trial Evaluating the Immunogenicity and Safety of an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.

Moldt Brian B, Ubeda Rafael A RA, Murray Alexander V AV, Tima Giresse G et al.

Influenza vaccines targeting both hemagglutinin (HA) and neuraminidase (NA) might offer broader protection than current vaccines, which primarily target HA. This randomized phase 2 study evaluated the immunogenicity and safety of an investigational mRNA-based trivalent seasonal influenza vaccine encoding HA and NA from A/H1N1, A/H3N2, and B/Victoria (FLUm3HA-3NA). Participants aged 18-64 years (younger adults) or 65-85 years (older adults) received one of several mRNA vaccine formulations-each containing different influenza A and B HA mRNA doses-or an age-appropriate licensed seasonal influenza vaccine as a comparator. Four formulations per age cohort were tested in part 1 of the study, and one formulation per age cohort in part 2. Day-29 hemagglutination inhibition (HI) and NA inhibition (NI) responses were assessed as primary and secondary endpoints, respectively, safety/reactogenicity as the secondary, and virus neutralization as the tertiary endpoint. A total of 250 younger and 260 older adults were vaccinated in part 1; 161 and 162, respectively, in part 2. All FLUm3HA-3NA formulations induced HI, NI, and neutralizing responses above baseline. In part 1, HI responses against A/H1N1 and A/H3N2 were similar or higher after FLUm3HA-3NA than after comparator vaccination in both age groups. For B/Victoria, HI responses were lower or similar versus comparator vaccination in younger adults and similar or higher in older adults. In part 2, HI responses were similar or higher with FLUm3HA-3NA versus comparators for A/H1N1 and A/H3N2, and lower for B/Victoria in both age groups. In both study parts and both age groups, NI titers were higher for all three strains with FLUm3HA-3NA versus comparators, and neutralizing titers were similar or higher for A/H1N1 and A/H3N2 and similar for B/Victoria. No safety concerns were identified. FLUm3HA-3NA induced HI, NI, and neutralizing responses, with an acceptable safety profile. The results support further development, including optimization of the influenza B HI response. ClinicalTrials.gov: NCT06431607.

PMID 42875682
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PubMedExpert opinion on investigational drugs2026-10-15

Targeting the proteasome in Leishmania donovani: developments from preclinical to Phase I and ii trials.

Sundar Shyam S, Singh Sarita S, Maurya Priya P, Singh Vishal Kumar VK et al.

Visceral leishmaniasis (VL), a neglected tropical disease caused by Leishmania donovani and L. infantum, which affects poor areas of South Asia, East Africa, and Brazil, and is fatal if left untreated. Current treatments, including liposomal amphotericin B, miltefosine, paromomycin, and pentavalent antimonials, are limited by emerging resistance, high cost, cold storage, need for parenteral administration. These drawbacks of the currently available therapy entail the development of a safe, short, and oral therapy for VL treatment. This review summarizes current knowledge of the Leishmania 20S proteasome as a therapeutic target, as it maintains protein homeostasis and exhibits structural variances from the human proteasome that allow selective, parasite-specific inhibition. It covers the preclinical story of GSK3494245 to the story of proteasome inhibitors, especially LXE408, which has progressed from Phase I evaluation to Phase II clinical trials in India and Ethiopia. Collectively, these results place proteasome inhibition as a promising clinical approach that may revolutionize the VL treatment. Proteasome inhibitors provide strong antiparasitic activity, high selectivity and a potential for oral treatment. If the ongoing clinical trials show safety, efficacy and durable cure rates, proteasome-targeting drugs will revolutionize VL therapy and be a model for drug development against other neglected tropical diseases.

PMID 42875406
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PubMedFrontiers in microbiology2026-10-15

Antifungal susceptibility and genomic profile associated with biosynthetic gene clusters of bovine mastitis-derived Aspergillus fumigatus DAH1043FM.

Prajapati Abhishek A, Parmar Pooja P, Chavan Monica M, Chandra Vartika V et al.

The most frequently isolated fungus from mycotic mastitis in cattle is Aspergillus fumigatus, which can cause infection by germinating on the animal's surface to form hyphae that penetrate epithelial and endothelial barriers and initiate mastitis. In this study, the fungal strain DAH1043FM was isolated from the milk of a cow with mastitis and identified as Aspergillus fumigatus by internal transcribed spacer (ITS) region sequencing. Species identity was further confirmed by whole-genome Average Nucleotide Identity (ANI) analysis. A. fumigatus DAH1043FM showed minimum inhibitory concentration (MIC) values of 0.5 μg/mL for amphotericin B and itraconazole, 0.12 μg/mL for posaconazole and voriconazole, 128 μg/mL for fluconazole, and >8 μg/mL for caspofungin, micafungin, and anidulafungin. Comparative Whole-genome sequencing (WGS) with two reference genomes of A. fumigatus, Af293 and A1163, was used to identify genetic variants, such as single nucleotide polymorphisms (SNPs) and other mutations, in genes associated with antifungal resistance, including those involved in drug efflux, ergosterol biosynthesis, echinocandin target pathways, and other resistance-related processes. Furthermore, genome mining identified biosynthetic gene clusters (BGCs) showing substantial similarity to characterized pathways associated with fumiquinazoline (100%), gliotoxin (84%), fumagillin (80%), and trypacidin (71%). These results demonstrate that strain DAH1043FM carries predicted genetic variants in target pathways while exhibiting wild-type susceptibility to azoles alongside off-scale endpoints for echinocandins. Genome analysis of strain DAH1043FM identified predicted secondary metabolite BGCs, highlighting the value of genome-level surveillance for fungal isolates recovered from bovine milk.

PMID 42876887
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PubMedFrontiers in immunology2026-10-15

Case Report: Multiple brain abscess-like lesions with concurrent detection of Nocardia amamiensis and Leishmania infantum in cerebrospinal fluid.

Liang Jiahao J, Wang Gang G, Shen Ruile R

Central nervous system nocardiosis is rare and potentially life-threatening, and human infection due to Nocardia amamiensis has seldom been reported; central nervous system involvement in visceral leishmaniasis is likewise uncommon. We report a 69-year-old man who developed progressive impairment of consciousness and coma after recurrent fever. Brain magnetic resonance imaging revealed multiple abscess-like lesions in both cerebral hemispheres, the cerebellum, and the brainstem, accompanied by acute or subacute cerebral infarctions. The cerebrospinal fluid opening pressure was 300 mmH2O. The white blood cell count was 285 × 106/L, with 81.9% polymorphonuclear cells; protein was 1.977 g/L and glucose was 2.34 mmol/L. MetaCAP analysis of cerebrospinal fluid concurrently detected N. amamiensis and L. infantum, and bone marrow smear demonstrated Leishmania amastigotes within macrophages. The patient tested negative for human immunodeficiency virus, and abdominal ultrasonography showed no hepatosplenomegaly. On the available evidence, visceral leishmaniasis was established and central nervous system nocardiosis was strongly suspected. Detection of L. infantum in cerebrospinal fluid supported possible central nervous system involvement, but did not establish a direct contribution to the brain abscess-like lesions. The patient received trimethoprim-sulfamethoxazole, imipenem-cilastatin, amikacin, and liposomal amphotericin B, but his condition continued to deteriorate. He was discharged against medical advice, and follow-up revealed that he had died. This case illustrates that sequencing-based detection is an important clue but cannot replace culture, pathogen-specific polymerase chain reaction, or evidence from lesion tissue.

PMID 42876631
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PubMedInfectious diseases and therapy2026-10-15

A Phase 1/2 Trial Evaluating the Safety and Immunogenicity of an mRNA-based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.

De Coster Ilse I, Cardona Jose F JF, Ferguson Murdo M, Leroux-Roels Isabel I et al.

Hemagglutinin (HA) is the principal immunologic target of most licensed seasonal influenza vaccines. Targeting both HA and neuraminidase (NA) might improve vaccine effectiveness. This randomized phase 1/2 study evaluated an investigational mRNA-based quadrivalent seasonal influenza vaccine, encoding HA and NA of A/H1N1, A/H3N2, B/Victoria, and B/Yamagata (FLUm4HA-4NA). In phase 1, adults aged 18-50 years received either one of twelve mRNA vaccine formulations of varying HA-only or HA and NA mRNA doses, or a licensed quadrivalent seasonal influenza comparator. In phase 2, participants aged 18-64 years (younger adults) and 65-85 years (older adults) received FLUm4HA-4NA (three groups per age category, with different HA/NA mRNA doses) or age-appropriate licensed quadrivalent comparator. Primary endpoints were safety/reactogenicity, and hemagglutination inhibition [HI] and NA inhibition [NI] responses against the four seasonal strains at day 29. Cross-reactive HI/NI responses against drifted strains, virus neutralization, and HA-/NA-specific cell-mediated immunity were evaluated in phase 2 as tertiary objectives. A total of 293 participants (21-25 per group) were vaccinated in phase 1, 480 younger (108-137 per group) and 483 older adults (117-125 per group) in phase 2. Solicited events were more frequent with FLUm4HA-4NA than comparators and were mostly short-lived and mild or moderate. No deaths or vaccine-related serious adverse events were reported. Post-vaccination HI and neutralizing titers in the FLUm4HA-4NA groups were similar or higher for the A strains and lower for the B strains versus comparators. NI responses exceeded those of comparators for all four strains. HI and NI titers against evaluated drifted A strains were similar or higher after FLUm4HA-4NA than after comparator vaccination. HA-specific CD4+ and CD8+ T-cell responses were generally higher after FLUm4HA-4NA than comparator vaccination. FLUm4HA-4NA showed an acceptable safety profile and humoral and cellular immunogenicity in the study population, supporting further development and formulation optimization to improve influenza B HI responses. ClinicalTrials.gov: NCT05823974; euclinicaltrials.eu: 2022-502308-66-00.

PMID 42875683
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