{
  "as_of": "2026-11-06",
  "title": "Injectable Fat Reduction Pipeline",
  "title_en": "Injectable Fat Reduction Pipeline",
  "slug": "injectable-fat-reduction",
  "assets": [
    {
      "section": "approved",
      "asset": "KYBELLA / BELKYRA (deoxycholic acid)",
      "asset_en": "KYBELLA / BELKYRA (deoxycholic acid)",
      "company": "AbbVie (formerly Allergan)",
      "company_en": "AbbVie (formerly Allergan)",
      "country": "US",
      "country_en": "US",
      "mechanism": "Deoxycholic acid; disrupts adipocyte membranes (cytolysis with local inflammation and swelling)",
      "mechanism_en": "Deoxycholic acid; disrupts adipocyte membranes (cytolysis with local inflammation and swelling)",
      "route": "Subcutaneous injection",
      "stage": "Approved",
      "stage_en": "Approved",
      "indication": "Moderate-to-severe submental fat",
      "indication_en": "Moderate-to-severe submental fat",
      "trials": [],
      "deal": "—",
      "latest": "FDA-approved in 2015; the first injectable fat-reduction drug approved by the FDA",
      "latest_en": "FDA-approved in 2015; the first injectable fat-reduction drug approved by the FDA",
      "date": "2015-04-29",
      "sources": [
        "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf",
        "https://pubmed.ncbi.nlm.nih.gov/27785706/"
      ],
      "asia": false
    },
    {
      "section": "approved",
      "asset": "VOILET (deoxycholic acid)",
      "asset_en": "VOILET (deoxycholic acid)",
      "company": "Daewoong Pharmaceutical",
      "company_en": "Daewoong Pharmaceutical",
      "country": "South Korea",
      "country_en": "South Korea",
      "mechanism": "Deoxycholic acid; disrupts adipocyte membranes",
      "mechanism_en": "Deoxycholic acid; disrupts adipocyte membranes",
      "route": "Subcutaneous injection",
      "stage": "Approved (Korea)",
      "stage_en": "Approved (Korea)",
      "indication": "Submental fat; investigator-initiated trial in anterior axillary fat cleared",
      "indication_en": "Submental fat; investigator-initiated trial in anterior axillary fat cleared",
      "trials": [],
      "deal": "—",
      "latest": "Approved in Korea in 2021; over 200,000 vials sold to 2,000+ clinics; July 2026 MOU with SNU Bundang Hospital and 365mc to expand to anterior axillary fat, then abdomen, arms and thighs",
      "latest_en": "Approved in Korea in 2021; over 200,000 vials sold to 2,000+ clinics; July 2026 MOU with SNU Bundang Hospital and 365mc to expand to anterior axillary fat, then abdomen, arms and thighs",
      "date": "2026-07-16",
      "sources": [
        "https://www.asiae.co.kr/en/article/2026071609305528497",
        "https://www.dailymedi.com/news/news_view.php?wr_id=911379"
      ],
      "asia": true
    },
    {
      "section": "approved",
      "asset": "Newbeju (cholic acid, MT921)",
      "asset_en": "Newbeju (cholic acid, MT921)",
      "company": "Medytox",
      "company_en": "Medytox",
      "country": "South Korea",
      "country_en": "South Korea",
      "mechanism": "Cholic acid; lower surfactant activity than deoxycholic acid",
      "mechanism_en": "Cholic acid; lower surfactant activity than deoxycholic acid",
      "route": "Subcutaneous injection",
      "stage": "Approved (Korea)",
      "stage_en": "Approved (Korea)",
      "indication": "Moderate-to-severe submental fat",
      "indication_en": "Moderate-to-severe submental fat",
      "trials": [
        "NCT05195112"
      ],
      "deal": "—",
      "latest": "Approved by Korea's MFDS on 2025-09-19; Phase 3 in 240 patients (completed Feb 2023) showed significantly greater MRI fat-volume reduction than placebo",
      "latest_en": "Approved by Korea's MFDS on 2025-09-19; Phase 3 in 240 patients (completed Feb 2023) showed significantly greater MRI fat-volume reduction than placebo",
      "date": "2025-09-19",
      "sources": [
        "https://www.asiae.co.kr/en/article/2025091917220932351",
        "https://www.asiae.co.kr/en/article/2023121815474699090",
        "https://clinicaltrials.gov/study/NCT05195112"
      ],
      "asia": true
    },
    {
      "section": "clinical",
      "asset": "CBL-514",
      "asset_en": "CBL-514",
      "company": "Caliway Biopharmaceuticals (TWSE: 6919)",
      "company_en": "Caliway Biopharmaceuticals (TWSE: 6919)",
      "country": "Taiwan",
      "country_en": "Taiwan",
      "mechanism": "Small molecule that induces adipocyte apoptosis",
      "mechanism_en": "Small molecule that induces adipocyte apoptosis",
      "route": "Subcutaneous injection",
      "stage": "Phase 3",
      "stage_en": "Phase 3",
      "indication": "Abdominal subcutaneous fat (large area); also cellulite and Dercum's disease (CBL-514D)",
      "indication_en": "Abdominal subcutaneous fat (large area); also cellulite and Dercum's disease (CBL-514D)",
      "trials": [
        "NCT07140939",
        "NCT07526974",
        "NCT07733947",
        "NCT07608770",
        "NCT06005441"
      ],
      "deal": "—",
      "latest": "Two global pivotal Phase 3 trials: SUPREME-01 (CBL-0301, ~320 participants, 13 US/Canada sites, enrollment announced Aug 2026) and SUPREME-02 (CBL-0302, ~320, US/Canada/Australia), results expected in 2027. Phase 2b CBL-0205 (n=173): 54.2% reached ≥20% fat-volume reduction vs 0% on placebo; mean reduction 166.6 mL (22.4%). FDA cleared a Phase 2 with tirzepatide. Asia-Pacific Phase 2 CBL-0206 (~250) approved in Taiwan and Australia, enrolling in Australia. China Phase 3 (CBL-0304) application planned for 2H 2026",
      "latest_en": "Two global pivotal Phase 3 trials: SUPREME-01 (CBL-0301, ~320 participants, 13 US/Canada sites, enrollment announced Aug 2026) and SUPREME-02 (CBL-0302, ~320, US/Canada/Australia), results expected in 2027. Phase 2b CBL-0205 (n=173): 54.2% reached ≥20% fat-volume reduction vs 0% on placebo; mean reduction 166.6 mL (22.4%). FDA cleared a Phase 2 with tirzepatide. Asia-Pacific Phase 2 CBL-0206 (~250) approved in Taiwan and Australia, enrolling in Australia. China Phase 3 (CBL-0304) application planned for 2H 2026",
      "date": "2026-08-25",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07140939",
        "https://clinicaltrials.gov/study/NCT07526974",
        "https://www.biospace.com/press-releases/caliway-announces-cbl-514-second-phase-2b-study-results-cbl-0205-met-endpoints",
        "https://www.biospace.com/press-releases/caliway-announces-u-s-fda-ind-clearance-for-cbl-0302-its-second-global-pivotal-phase-3-study-of-cbl-514",
        "https://www.placera.se/pressmeddelanden/caliway-s-cbl-514-combination-therapy-cleared-by-u-s-fda-for-phase-2-trial-pivotal-phase-3-trial-supreme-01-initiates-enrollment-20260826"
      ],
      "asia": true,
      "client": true
    },
    {
      "section": "clinical",
      "asset": "RZL-012",
      "asset_en": "RZL-012",
      "company": "Raziel Therapeutics (China rights: Fosun Pharma affiliate JuveStar)",
      "company_en": "Raziel Therapeutics (China rights: Fosun Pharma affiliate JuveStar)",
      "country": "Israel / China",
      "country_en": "Israel / China",
      "mechanism": "Injectable lipolytic molecule that destroys targeted fat cells",
      "mechanism_en": "Injectable lipolytic molecule that destroys targeted fat cells",
      "route": "Subcutaneous injection",
      "stage": "Phase 3 completed (China)",
      "stage_en": "Phase 3 completed (China)",
      "indication": "Submental fat; Fosun planning a body-contouring trial",
      "indication_en": "Submental fat; Fosun planning a body-contouring trial",
      "trials": [
        "NCT05763160"
      ],
      "deal": "2020 license for mainland China, Hong Kong, Macau and Taiwan: up to US$74M in milestones (US$27M pre-approval, US$47M sales) plus tiered royalties",
      "deal_en": "2020 license for mainland China, Hong Kong, Macau and Taiwan: up to US$74M in milestones (US$27M pre-approval, US$47M sales) plus tiered royalties",
      "latest": "On 2026-09-02, the China Phase 3 (n=480) showed a 30-percentage-point responder-rate advantage over placebo; NDA to China's regulator planned by end of 2026",
      "latest_en": "On 2026-09-02, the China Phase 3 (n=480) showed a 30-percentage-point responder-rate advantage over placebo; NDA to China's regulator planned by end of 2026",
      "date": "2026-09-02",
      "sources": [
        "https://www.prnewswire.com/il/news-releases/raziel-therapeutics-and-fosun-pharma-announce-positive-phase-3-results-for-rzl-012-in-submental-fat-reduction-clearing-the-path-to-a-china-nda-filing-302867570.html",
        "https://www.calcalistech.com/ctech/articles/0,7340,L-3850958,00.html"
      ],
      "asia": true,
      "trials_display": "China Phase 3 is not registered on ClinicalTrials.gov; NCT05763160 is a US Phase 2 open-label trial (15 participants, completed 2023)"
    },
    {
      "section": "clinical",
      "asset": "AYP-101 (polyene phosphatidylcholine)",
      "asset_en": "AYP-101 (polyene phosphatidylcholine)",
      "company": "AMI Pharm",
      "company_en": "AMI Pharm",
      "country": "South Korea",
      "country_en": "South Korea",
      "mechanism": "Polyene phosphatidylcholine; induces adipocyte apoptosis without an inflammatory response",
      "mechanism_en": "Polyene phosphatidylcholine; induces adipocyte apoptosis without an inflammatory response",
      "route": "Subcutaneous injection",
      "stage": "Phase 3 completed",
      "stage_en": "Phase 3 completed",
      "indication": "Submental fat",
      "indication_en": "Submental fat",
      "trials": [
        "NCT06256445"
      ],
      "deal": "—",
      "latest": "Korean Phase 3 (n=252) completed, results not yet published; in Phase 2, over 70% improved by at least one grade",
      "latest_en": "Korean Phase 3 (n=252) completed, results not yet published; in Phase 2, over 70% improved by at least one grade",
      "date": "2025-08-11",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06256445",
        "https://modernaesthetics.com/news/ami-pharm-advances-ayp-101-to-phase-3-testing-for-noninflammatory-fat-reduction/2476093/"
      ],
      "asia": true
    },
    {
      "section": "clinical",
      "asset": "CU-20401 (recombinant mutant collagenase)",
      "asset_en": "CU-20401 (recombinant mutant collagenase)",
      "company": "Cutia Therapeutics (HKEX: 2487)",
      "company_en": "Cutia Therapeutics (HKEX: 2487)",
      "country": "China",
      "country_en": "China",
      "mechanism": "Acts on the extracellular matrix surrounding fat tissue",
      "mechanism_en": "Acts on the extracellular matrix surrounding fat tissue",
      "route": "Subcutaneous injection",
      "stage": "Phase 2 completed",
      "stage_en": "Phase 2 completed",
      "indication": "Submental fat",
      "indication_en": "Submental fat",
      "trials": [
        "NCT06194188"
      ],
      "deal": "—",
      "latest": "On 2024-11-29, the China Phase 2 (n=108) showed significantly higher response rates than placebo at both doses, with no serious adverse events",
      "latest_en": "On 2024-11-29, the China Phase 2 (n=108) showed significantly higher response rates than placebo at both doses, with no serious adverse events",
      "date": "2024-11-29",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06194188",
        "https://www.itiger.com/news/2487376028"
      ],
      "asia": true
    },
    {
      "section": "clinical",
      "asset": "STP705 (siRNA)",
      "asset_en": "STP705 (siRNA)",
      "company": "Sirnaomics (HKEX: 2257)",
      "company_en": "Sirnaomics (HKEX: 2257)",
      "country": "US / China",
      "country_en": "US / China",
      "mechanism": "siRNA that silences TGF-β1 and COX-2",
      "mechanism_en": "siRNA that silences TGF-β1 and COX-2",
      "route": "Subcutaneous injection",
      "stage": "Phase 2",
      "stage_en": "Phase 2",
      "indication": "Submental fat",
      "indication_en": "Submental fat",
      "trials": [
        "NCT07677683"
      ],
      "deal": "—",
      "latest": "Australian Phase 2 (n=30) began enrolling on 2026-07-28",
      "latest_en": "Australian Phase 2 (n=30) began enrolling on 2026-07-28",
      "date": "2026-07-28",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07677683"
      ],
      "asia": false
    },
    {
      "section": "clinical",
      "asset": "10XB-101",
      "asset_en": "10XB-101",
      "company": "10xBio",
      "company_en": "10xBio",
      "country": "US",
      "country_en": "US",
      "mechanism": "Not disclosed",
      "mechanism_en": "Not disclosed",
      "route": "Subcutaneous injection",
      "stage": "Phase 2 completed",
      "stage_en": "Phase 2 completed",
      "indication": "Submental fat",
      "indication_en": "Submental fat",
      "trials": [
        "NCT05154955"
      ],
      "deal": "—",
      "latest": "US Phase 2 (n=51) completed in March 2024",
      "latest_en": "US Phase 2 (n=51) completed in March 2024",
      "date": "2024-03-19",
      "sources": [
        "https://clinicaltrials.gov/study/NCT05154955"
      ],
      "asia": false
    },
    {
      "section": "clinical",
      "asset": "HY-2003 (liposomal deoxycholic acid)",
      "asset_en": "HY-2003 (liposomal deoxycholic acid)",
      "company": "Sichuan Huiyu Pharmaceutical",
      "company_en": "Sichuan Huiyu Pharmaceutical",
      "country": "China",
      "country_en": "China",
      "mechanism": "Liposome-encapsulated deoxycholic acid",
      "mechanism_en": "Liposome-encapsulated deoxycholic acid",
      "route": "Subcutaneous injection",
      "stage": "Phase 1",
      "stage_en": "Phase 1",
      "indication": "Submental fat",
      "indication_en": "Submental fat",
      "trials": [
        "NCT06756490"
      ],
      "deal": "—",
      "latest": "China Phase 1 (n=30) versus BELKYRA and placebo; primary completion December 2026",
      "latest_en": "China Phase 1 (n=30) versus BELKYRA and placebo; primary completion December 2026",
      "date": "2024-12-26",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06756490"
      ],
      "asia": true
    },
    {
      "section": "clinical",
      "asset": "Ronkyla Plus (new sodium deoxycholate formulation)",
      "asset_en": "Ronkyla Plus (new sodium deoxycholate formulation)",
      "company": "Glonova Pharma",
      "company_en": "Glonova Pharma",
      "country": "Taiwan",
      "country_en": "Taiwan",
      "mechanism": "Sodium deoxycholate that forms a hydrogel at the injection site",
      "mechanism_en": "Sodium deoxycholate that forms a hydrogel at the injection site",
      "route": "Intralesional injection",
      "stage": "Phase 1",
      "stage_en": "Phase 1",
      "indication": "Superficial lipoma; submental fullness",
      "indication_en": "Superficial lipoma; submental fullness",
      "trials": [
        "NCT07237425"
      ],
      "deal": "—",
      "latest": "Taiwan Phase 1 (n=56, 3 sites) enrolling since November 2025",
      "latest_en": "Taiwan Phase 1 (n=56, 3 sites) enrolling since November 2025",
      "date": "2025-11-14",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07237425"
      ],
      "asia": true
    },
    {
      "section": "discontinued",
      "asset": "Qwo (collagenase clostridium histolyticum-aaes)",
      "asset_en": "Qwo (collagenase clostridium histolyticum-aaes)",
      "company": "Endo",
      "company_en": "Endo",
      "country": "US",
      "country_en": "US",
      "mechanism": "Collagenase that releases the fibrous septae behind dimpling",
      "mechanism_en": "Collagenase that releases the fibrous septae behind dimpling",
      "route": "Subcutaneous injection",
      "stage": "Discontinued",
      "stage_en": "Discontinued",
      "indication": "Cellulite of the buttocks in adult women",
      "indication_en": "Cellulite of the buttocks in adult women",
      "trials": [],
      "deal": "—",
      "latest": "FDA-approved in 2020; production and sales ended in December 2022 over the extent and variability of bruising and possible prolonged skin discoloration",
      "latest_en": "FDA-approved in 2020; production and sales ended in December 2022 over the extent and variability of bruising and possible prolonged skin discoloration",
      "date": "2022-12-12",
      "sources": [
        "https://practicaldermatology.com/news/endo-removes-qwo-from-market-due-to-concerns-about-injection-site-bruising-skin-discoloration/2461467/",
        "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761146s000lbl.pdf"
      ],
      "asia": false
    }
  ],
  "summary_expected": {
    "total": 12,
    "approved": 3,
    "clinical": 8,
    "phase3_including_completed": 3,
    "discontinued": 1,
    "asia_company_or_partner_in_clinical": 6,
    "large_area_phase3": 1
  }
}