Data updated: Jun 28, 2026
ABSORICA LD (isotretinoin) · Sun Pharma
Dermatology
Approved 2019-11-05
ABSORICA LD is FDA-approved to treat 1 condition (same as MYORISAN).
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-11-05
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ABSORICA LD Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 2019 to 2026
What ABSORICA LD Treats
1 indicationsABSORICA LD is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as MYORISAN (same active ingredient).
Source: FDA Label
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06172296 | NCI-2023-08530 NCI-2023-08530, ANBL2131 | Ph 3 | recruiting | Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma |
| NCT07481370 | 0849-25-FB | Ph 2 | enrolling by invitation | Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm |
| NCT01857934 results posted | NB2012 NCI-2013-00034 | Ph 2 | completed | Therapy for Children With Advanced Stage Neuroblastoma |
| NCT01711554 | NCI-2012-02011 NCI-2012-02011, CDR0000741991 | Ph 1 | active not recruiting | Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma |
| NCT03786783 results posted | NCI-2018-03732 NCI-2018-03732, ANBL17P1 | Ph 2 | completed | Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT01175356 results posted | ANBL09P1 NCI-2011-01745, ANBL09P1 | Ph 1 | completed | Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin |
| NCT04385277 results posted | ANBL19P1 NCI-2020-02950, ANBL19P1 | Ph 2 | active not recruiting | Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) |
| NCT03033303 | 16-1643 | Ph 2 | completed | A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma |
| NCT03076021 results posted | STUDY00002324 R01GM124264 | Ph 4 | completed | Effects of Isotretinoin on CYP2D6 Activity |
| NCT06698263 ARESPERM | 7345 2024-519644-33-00 | Ph 4 | not yet recruiting | 13-cis Retinoic Acid (Isotretinoin) and Sperm Production |
| NCT01969058 results posted | ACTG A5325 UM1AI068636 | Ph 2 | completed | Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery |
| NCT04940767 | V77-123 | Ph 4 | completed | A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris |
| NCT05684861 | SVU MED DVA021 4 22 11 508 | Ph 2 | completed | Serum TWEAK Levels in Acne Vulgaris |
| NCT05529888 | 322/1/19 | Ph 4 | completed | Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin. |
| NCT04909515 | 202 | Ph 2 | withdrawn | Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. |
| NCT04154293 results posted | 235-9051-202 1R01FD006079-01A1 | Ph 2 | completed | A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis |
| NCT01560585 results posted | ISOTRT-01 | Ph 1, Ph 2 | terminated | Open Label Study of Isotretinoin in Mild to Moderate Alzheimer's Disease |
| NCT04594759 WIT results posted | 00103493 | Ph 1, Ph 2 | completed | Weekly Isotretinoin Therapy Study |
| NCT00867178 | NCI-2012-03167 NCI-2012-03167, PBTC-026 | Ph 1 | completed | Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System |
| NCT01041638 results posted | NCI-2011-01997 NCI-2011-01997, COG-ANBL0931 | Ph 3 | completed | Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma |
| NCT02457520 results posted | ABS157LT | Ph 4 | completed | ABSORICA in Patients With Severe Recalcitrant Nodular Acne |
| NCT01474590 POWER results posted | RD.03.SPR.29099 | Ph 3 | completed | Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne |
| NCT01334515 results posted | ANBL1021 NCI-2011-02672, CDR0000698589 | Ph 2 | completed | Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma |
| NCT01103375 | IRB00012306 NCI-2010-00132, CCCWFU 91209 | Ph 1 | terminated | Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma |
| NCT01445028 DELIVER results posted | WEI-DELIVER | Ph 4 | completed | Isotretinoin for Proliferative Vitreoretinopathy |
| NCT01208454 | NCI-2011-02522 NCI-2011-02522, N2008-02 | Ph 1 | completed | Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma |
| NCT01592045 results posted | DIV-NB-201 | Ph 1, Ph 2 | completed | ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma |
| NCT00975143 results posted | ISOCT.08.01 | Ph 3 | completed | Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne |
| NCT01319838 Aflac ST1001 | IRB00047148 Aflac ST1001 | Ph 1 | withdrawn | Aflac ST1001 Prolonged Isotretinoin |
| NCT01888224 | 618-10 | Ph 1 | completed | Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition |
| NCT01861626 | V00057 CA 1 01 2013-000988-80 | Ph 1 | completed | Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects |
| NCT01404130 | 07/S0802/135 | Ph 4 | completed | A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory |
| NCT07629167 PNOC039 | 250833 NCI-2026-04129 | Ph 2 | not yet recruiting | Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway |
| NCT07639073 | PIMS-DERM-ISO-2026-01 | Ph 4 | not yet recruiting | Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ABSORICA LD FDA Label Details
Indications & Usage
FDA Label (PDF)ABSORICA LD is FDA-approved to treat 1 condition — same approved indications as MYORISAN.
View full patent landscape →
2 OB patents · 2 families ·
18 international docs across 11 countries
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Revenue Insights
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Patent Timeline
- • Cliff: 2035
- • 72 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.