U.S. label recordMetabolic

Insulin glargine-aldy

Related names in cited records: Langlara

A long-acting insulin analogue. This profile cites a U.S. prescription label.

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Insulin glargine-aldy and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

Status sources checked through July 22, 2026. See status sources and coverage →

What does the U.S. product label say?

Langlara · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited Langlara label covers glycemic control in adults and children with diabetes mellitus. It does not cover treatment of diabetic ketoacidosis. Label: 1 ↗

What clinical studies does the label describe?

Section 14 summarizes open-label randomized comparisons of insulin glargine with NPH insulin involving 2,327 adults and 349 children with type 1 diabetes and 1,563 adults with type 2 diabetes. HbA1c reductions were generally similar. These are the label’s insulin-glargine clinical studies, not a count of trials conducted specifically with insulin glargine-aldy. Label: 14.1, 14.2, 14.3 ↗

Which safety limits matter?

The label describes potentially life-threatening hypoglycemia, severe hypersensitivity, low potassium, medication errors and fluid retention or heart failure with thiazolidinediones. Hypoglycemia episodes and relevant hypersensitivity are contraindications. Label: 4, 5 ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

LANGLARA (insulin glargine-aldy) injection, solution · SPL version 5 · published 2026-07-08

Label ZIP SHA-256: c393585bbdb741f3ff47b5db3b45ed1dfc84a10d2d03e83796d8aae94d3ad187. Extracted XML SHA-256: a785c2958a54aeb8984fecab009a9c899d5b73479104b4d2ae4982ac6f32f770.

Open versioned label context data →

What remains unresolved?

This account summarizes the cited product label. A separate appraisal of the complete clinical literature and other jurisdictions remains open.

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Scoped peptide/product-name PubMed query. The aldy-specific query does not search the full parent insulin glargine literature.

0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

aldy[All Fields] AND insulin[All Fields]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:07:09.030685+00:00 · HTTP 200 · SHA-256 1e01cb15bf53366528ed59074e9f9113c824ed986d99842df0a81b323fa1e6e3.

  • A scoped product-label account is available separately; it is not an independent literature review.
  • Other aliases, parent molecules, study-family linkage and full-text appraisal remain separate work.
  • Zero aldy-and-insulin name matches do not mean zero human evidence. The product label draws on reference insulin glargine studies; those parent studies must not be described as trials conducted specifically with the biosimilar.

Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    FDA search

    Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

    1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    products.active_ingredients.name:"INSULIN GLARGINE-ALDY"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:10:16.355362+00:00 · HTTP 200 · SHA-256 9d9b9554d36dad7859e00002365c43768fc72d347d3226e47be96c436e4ab0fb.

    • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
    • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

    Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    1. FDA BLA761412 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: INSULIN GLARGINE-ALDY.

    EMA search

    Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

    0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    Case-insensitive word-boundary identity terms: ["Insulin glargine-aldy", "Langlara"]

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

    • Document appraisal and national European sources remain open.
    • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

    Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

      EMA search

      Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

      0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

      Search terms, record decisions and remaining work

      Case-insensitive word-boundary identity terms: ["Insulin glargine-aldy", "Langlara"]

      Source retrievals and payload pins
      • Open the source endpoint ↗

        Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

      • Document appraisal and national European sources remain open.
      • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

      Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

        EMA search

        Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

        0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

        Search terms, record decisions and remaining work

        Case-insensitive word-boundary identity terms: ["Insulin glargine-aldy", "Langlara"]

        Source retrievals and payload pins
        • Open the source endpoint ↗

          Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

        • Document appraisal and national European sources remain open.
        • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

        Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

          ClinicalTrials.gov search

          ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

          0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

          Search terms, record decisions and remaining work

          "Insulin glargine-aldy" OR "Langlara"

          Source retrievals and payload pins
          • Open the source endpoint ↗

            Retrieved 2026-09-15T11:26:14.448759+00:00 · HTTP 200 · SHA-256 b54968c05ff881a1ef7ce604b6a340248f8e2aee8637bef06da0f5693f520df8.

          • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
          • Other registries, unregistered studies and additional aliases remain outside this query.

          Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

            Explore status sources, recent additions, and coverage gaps

            Living status brief

            What is the current status of Insulin glargine-aldy?

            U.S. label record. The cited DailyMed label identifies Insulin glargine-aldy and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

            The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

            Evidence present

            What records are connected here?

            Evidence lanes
            1
            Source years
            1
            Drugs@FDA applications
            1

            These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

            Coverage gaps

            What remains unknown or unsupported?

            PeptideScanner currently has no selected clinical trial records, PubMed literature metadata records, and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

            PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

            Explore the Evidence Map and record counts

            Evidence Map v1

            What kinds of records connect to Insulin glargine-aldy?

            Compare collection coverage →

            This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

            4Selected dated records
            5Connected citations
            1Populated source years2026
            1/4Record lanes present

            Registered human studies

            Trial composition

            0 of 0 selected trial records include at least one phase value; 0 of 0 include a status value in the retained structured contract.

            PubMed bibliography

            Publication composition

            0 of 0 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

            Regulatory and publication surfaces

            What is structurally connected?

            Drugs@FDA applications
            1
            FDA Federal Register documents
            0
            DailyMed SPL versions
            3
            Canonical profile
            Published
            Profile structured data
            Published
            Linked dated records
            4

            Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

            Profile publication history and record counts

            Research hub

            Explore the Insulin glargine-aldy evidence record

            Open all 4 records →
            4Dated records
            1Evidence type
            4Cited public sources
            1Source year

            Change ledger

            Recently changed for Insulin glargine-aldy

            Open all 5 events →

            PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

            Record added

            Insulin glargine-aldy DailyMed SPL version 1

            DailyMed lists Structured Product Labeling version 1 for the reviewed Insulin glargine-aldy label family with a published date of 2026-06-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            PeptideScanner change date
            August 22, 2026
            Cited source date
            June 2, 2026
            Evidence lane
            Regulatory
            Record added

            Insulin glargine-aldy DailyMed SPL version 2

            DailyMed lists Structured Product Labeling version 2 for the reviewed Insulin glargine-aldy label family with a published date of 2026-06-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            PeptideScanner change date
            August 22, 2026
            Cited source date
            June 5, 2026
            Evidence lane
            Regulatory
            Record added

            Insulin glargine-aldy DailyMed SPL version 5

            DailyMed lists Structured Product Labeling version 5 for the reviewed Insulin glargine-aldy label family with a published date of 2026-07-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            PeptideScanner change date
            August 22, 2026
            Cited source date
            July 8, 2026
            Evidence lane
            Regulatory

            Official-source collections

            Source records for Insulin glargine-aldy

            Open the full research atlas →

            Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

            Evidence types

            Coverage by source year

            Selected records span April 29, 2026 to July 8, 2026.

            Continue exploring

            Profiles with overlapping source-year coverage

            Open the research atlas →

            These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

            Glucagon1 shared source year308 dated records · 4 evidence typesSemaglutide1 shared source year237 dated records · 4 evidence typesLeuprolide1 shared source year215 dated records · 4 evidence typesTirzepatide1 shared source year169 dated records · 4 evidence types

            These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

            Evidence summary

            What the cited records say

            The cited DailyMed label identifies Insulin glargine-aldy and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

            This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

            Cited context

            Related records

            Organizations named in cited records

            • U.S. National Library of Medicine

            Dated source history

            Updates connected to this profile

            Open the full cross-source timeline →
            1. Regulatory

              Insulin glargine-aldy DailyMed SPL version 5

              DailyMed lists Structured Product Labeling version 5 for the reviewed Insulin glargine-aldy label family with a published date of 2026-07-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            2. Regulatory

              Insulin glargine-aldy DailyMed SPL version 2

              DailyMed lists Structured Product Labeling version 2 for the reviewed Insulin glargine-aldy label family with a published date of 2026-06-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            3. Regulatory

              Insulin glargine-aldy DailyMed SPL version 1

              DailyMed lists Structured Product Labeling version 1 for the reviewed Insulin glargine-aldy label family with a published date of 2026-06-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

            4. Regulatory

              Drugs@FDA application BLA761412

              The official Drugs@FDA dataset lists original submission 1 for BLA 761412 with status AP dated 2026-04-29, and names insulin glargine-aldy among the application record's active ingredients.